What this pack is
Amoxil is the brand name in this record; amoxicillin is the generic name. Read both together with the dosage form (multiple oral forms (tablets, oral liquid and chewable tablets)).
PACK CHECK · MARKET FIRST
AmoxilGeneric nameamoxicillin
Mainland China pack-name cue阿莫仙®Historical or public source cue · verify the current target-market record
How this medicine works
The FDA AMOXIL brand label describes amoxicillin as bactericidal through inhibition of bacterial cell-wall biosynthesis. This explains a pathway against susceptible bacteria; it does not establish that an individual's symptoms are bacterial or decide whether to use it, which product to select, how many tablets or how many millilitres.
Read source: United States ↗Historical public record · reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 阿莫仙®
- International brand name
- Amoxil
- Generic name
- amoxicillin
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
Mainland China trade-name search cue:阿莫仙®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
This AMOXIL NDA dossier contains 500/875 mg tablets, 200/400 mg per 5 mL suspension and 125/200/250/400 mg chewables. A separate current AMOXICILLIN ANDA label contains 250/500 mg capsules and 125/250 mg per 5 mL suspension; shared ingredient or AMOXIL imprint does not merge those products. None of these strengths answers ‘how many tablets, capsules or millilitres.’
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
8 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050754 · Orange Book DISCN · RLD
500 mg; 100-tablet bottle, 500-tablet bottle or 20-tablet pack
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-024-01 / 81964-024-05 / 81964-024-14
- Form and route
- AMOXIL amoxicillin film-coated oral tablet · oral
- Container
- 100-tablet bottle, 500-tablet bottle or 20-tablet pack
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pink · capsule-shaped film-coated tablet · imprint AMOXIL / 500
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050754 · Orange Book DISCN · RLD
875 mg; 100-tablet bottle or 20-tablet pack
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-019-01 / 81964-019-14
- Form and route
- AMOXIL amoxicillin film-coated oral tablet · oral
- Container
- 100-tablet bottle or 20-tablet pack
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 875 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pink · capsule-shaped film-coated tablet; scored, but the score is not self-splitting permission · imprint AMOXIL / 875Scored appearance; this is not a self-splitting instruction
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050760 · Orange Book DISCN · RLD
200 mg/5 mL; 50, 75 or 100 mL bottle after reconstitution
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-023-50 / 81964-023-51 / 81964-023-52
- Form and route
- AMOXIL amoxicillin oral suspension after reconstitution · oral
- Container
- 50, 75 or 100 mL bottle after reconstitution
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 200 mglabelled amount per 5 mL after reconstitution; not an individual's millilitre amount, preparation or measuring instruction
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050760 · Orange Book RX · RLD · AB
400 mg/5 mL; 50, 75 or 100 mL bottle after reconstitution
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-007-50 / 81964-007-51 / 81964-007-52
- Form and route
- AMOXIL amoxicillin oral suspension after reconstitution · oral
- Container
- 50, 75 or 100 mL bottle after reconstitution
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 400 mglabelled amount per 5 mL after reconstitution; not an individual's millilitre amount, preparation or measuring instruction
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050542 · Orange Book DISCN · RLD
125 mg; 60- or 100-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-026-60 / 81964-026-01
- Form and route
- AMOXIL amoxicillin chewable tablet · oral
- Container
- 60- or 100-tablet bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 125 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pale pink · round chewable tablet · imprint AMOXIL / 125
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050761 · Orange Book DISCN
200 mg; 20-tablet unit-dose pack
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-028-14
- Form and route
- AMOXIL amoxicillin chewable tablet · oral
- Container
- 20-tablet unit-dose pack
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 200 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pale pink · round chewable tablet; contains aspartame, so people with phenylketonuria need exact-label review · imprint AMOXIL / 200
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050542 · Orange Book DISCN · RLD
250 mg; 30- or 100-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-027-30 / 81964-027-01
- Form and route
- AMOXIL amoxicillin chewable tablet · oral
- Container
- 30- or 100-tablet bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 250 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pale pink · round chewable tablet · imprint AMOXIL / 250
United States label · FDA AMOXIL brand label (revised May 2024) · NDA 050761 · Orange Book DISCN
400 mg; 20-tablet unit-dose pack or 100-tablet bottle
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDC 81964-029-14 / 81964-029-01
- Form and route
- AMOXIL amoxicillin chewable tablet · oral
- Container
- 20-tablet unit-dose pack or 100-tablet bottle
- Listing review
- Cited product evidence reviewed 2026-08-30; actual marketing, stock and availability are not established.
- amoxicillin
- 400 mglabelled amount per tablet; not an individual's tablet count, splitting or conversion instruction
- Labelled appearance
- pale pink · capsule-shaped chewable tablet; contains aspartame, so people with phenylketonuria need exact-label review · imprint AMOXIL / 400
SEPARATE REGULATORY PRODUCT COMPARISON
Current ANDA package comparison — not the AMOXIL NDA brand pack
These eight images come from the current U.S. AMOXICILLIN ANDA 062216 public label. They are shown only to help check strength, bottle count, NDC and capsule clues. An AMOXIL imprint does not turn these ANDA cards into the AMOXIL NDA brand pack, originator proof, another-market product, authenticity result, prescription or current-stock claim.
250/500 mg is the labelled amount per capsule; 60/100/500 is the bottle count. Neither number determines an individual's amount or course.
This AMOXIL NDA dossier contains 500/875 mg tablets, 200/400 mg per 5 mL suspension and 125/200/250/400 mg chewables. A separate current AMOXICILLIN ANDA label contains 250/500 mg capsules and 125/250 mg per 5 mL suspension; shared ingredient or AMOXIL imprint does not merge those products. None of these strengths answers ‘how many tablets, capsules or millilitres.’
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
8 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 250 mg per capsule; 100-capsule bottle
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-225-01
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle
- Units in each inner container
- 100 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 250 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 250Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 250 mg per capsule; 500-capsule bottle
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-225-05
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle
- Units in each inner container
- 500 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 250 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 500 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 250Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 100-capsule bottle
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-205-01
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle
- Units in each inner container
- 100 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 500-capsule bottle
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-205-05
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle
- Units in each inner container
- 500 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 500 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-205-10
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle with child-resistant closure
- Units in each inner container
- 100 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-205-60
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle with child-resistant closure
- Units in each inner container
- 60 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 60 capsules per bottle
- Labelled appearance
- pink and royal blue · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-350-10
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle with child-resistant closure
- Units in each inner container
- 100 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 100 capsules per bottle
- Labelled appearance
- white · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
United States label · Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026
Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure
This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim.
- Product code
- NDC 81964-350-60
- Form and route
- AMOXICILLIN amoxicillin oral capsule (separate ANDA product) · oral (label product-identity field)
- Container
- bottle with child-resistant closure
- Units in each inner container
- 60 capsules per bottlePackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- amoxicillin
- 500 mglabelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction
- Package
- 60 capsules per bottle
- Labelled appearance
- white · capsule; unscored · imprint AMOXIL / 500Unscored in this labelled presentation
PACKAGE-VISUAL STATUS
The AMOXIL brand label for four NDAs was reviewed, but no official image matching one exact original-brand pack was retained, so no package visual is shown
The 2024 FDA brand label provides strengths, NDCs, packaging and appearance text for tablets, suspension and chewables, but no official image was retained that can safely be displayed and matched to one exact AMOXIL NDA pack. The previously used 250/500 mg capsule images come from a different AMOXICILLIN ANDA label and cannot serve as AMOXIL original-brand appearance. To prevent confusion, the page uses eight source-text identity cards and retains the ANDA comparator source for verification.
LABEL READING · NOT A PRESCRIPTION
AMOXIL label reading: separate the NDA brand forms from a different ANDA generic label
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 2024 FDA AMOXIL brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension after reconstitution, and 125/200/250/400 mg chewables. The current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension belong to a different AMOXICILLIN ANDA label and cannot be merged into the AMOXIL NDA brand pack.
- ‘500 mg per tablet’ and ‘400 mg per 5 mL’ are label units for different forms. Pack numbers cannot answer how many tablets or millilitres an individual should take; diagnosis, age or weight, kidney function, exact product, prescription and target-market label are all required.
- The score on the 875 mg tablet is an appearance feature of that labelled product, not permission to halve, reduce or substitute another strength. Splitting, administration or changing to suspension requires the exact current label and pharmacist review against the prescription.
- The 200 mg and 400 mg chewables contain aspartame, and the FDA label lists phenylalanine information. This does not mean they are unsuitable for everyone, but phenylketonuria and related concerns require review of the exact product with a professional.
- With a serious penicillin or cephalosporin allergy history, breathing trouble or widespread rash after use, severe or persistent diarrhoea, or co-use of anticoagulants, allopurinol or other medicines, contact a local clinician or pharmacist promptly. Severe breathing difficulty, face/lip/tongue swelling or fainting requires emergency care.
- Older age does not automatically determine an amount. The FDA label notes that amoxicillin is substantially excreted by the kidney and risk may be greater with impaired renal function. Ask the prescribing team to review kidney function and the complete medicine list; do not self-reduce, alternate days or change strength.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 4
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: AMOXIL amoxicillin brand prescribing information (four NDAs; revised May 2024) ↗Historical public record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-30FDA: AMOXIL supplement approval letter for four NDAs (9 Jun 2022) ↗Current regulatory record · reviewed 2026-08-30
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book data files (AMOXIL NDA product-status review) ↗reviewed 2026-08-29
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-02DailyMed (NLM): separate AMOXICILLIN capsule/suspension ANDA label (must not be merged into AMOXIL NDA products) ↗Current regulatory record · reviewed 2026-09-02
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA FAERS record: labelling-update information for amoxicillin-related products2023-09-30 · FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Amoxil and several amoxicillin-containing products and states that Warnings and Precautions and Adverse Reactions were updated in May 2024 with drug-induced enterocolitis syndrome (DIES) information. This is an FDA safety-signal and labelling-update record; it does not diagnose symptoms or replace the exact product’s current target-market label and professional review.Primary-source record (open linked document) ↗reviewed 2026-08-22
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Amoxil (amoxicillin). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Amoxil is the brand in this record and amoxicillin is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- FDA: AMOXIL amoxicillin brand prescribing information (four NDAs; revised May 2024) ↗Historical public record · reviewed 2026-08-30
- FDA: AMOXIL supplement approval letter for four NDAs (9 Jun 2022) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book data files (AMOXIL NDA product-status review) ↗reviewed 2026-08-29
- DailyMed (NLM): separate AMOXICILLIN capsule/suspension ANDA label (must not be merged into AMOXIL NDA products) ↗Current regulatory record · reviewed 2026-09-02
HOW IT WORKS · NOT A TREATMENT PLAN
How amoxicillin works: it affects bacterial cell-wall building during growth
- A “cell wall” can be read as part of the structure a bacterium needs to maintain itself. This pathway concerns bacteria; it cannot decide whether a cold, sore throat, cough or another symptom needs an antibacterial medicine. The need for treatment still depends on diagnosis, testing and the current target-market label.
- “Susceptible organisms” is a key label limitation: a mechanism is not a treatment promise for every pathogen, infection site or person. Do not retain, borrow, increase, shorten or extend amoxicillin because a similar symptom was treated with it in the past.
- A shared mechanism does not turn AMOXIL NDA tablets, suspension and chewables and a separate ANDA capsule label into the same product, nor does it create a self-conversion formula for tablets, capsules or millilitres.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- FDA: AMOXIL amoxicillin brand prescribing information (four NDAs; revised May 2024) ↗Historical public record · reviewed 2026-08-30
- FDA: AMOXIL supplement approval letter for four NDAs (9 Jun 2022) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book data files (AMOXIL NDA product-status review) ↗reviewed 2026-08-29
- DailyMed (NLM): separate AMOXICILLIN capsule/suspension ANDA label (must not be merged into AMOXIL NDA products) ↗Current regulatory record · reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
Amoxilamoxicillin
This page links to public primary-source material for Amoxil. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
LABEL USE SNAPSHOT
What the cited U.S. label covers
U.S. FDA label snapshot, revised May 2024: for certain infections due to susceptible organisms in the ear, nose and throat, genitourinary tract, skin and skin structures, and lower respiratory tract; specified adult H. pylori and duodenal-ulcer combination treatment is also listed.
It is source-reading context, not an individual diagnosis, prescription, substitution or purchasing recommendation. Check the current label in the target market.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year
The FDA AMOXIL brand label lists Initial U.S. Approval: 1974; this does not establish another market or current supply.
FDA: AMOXIL brand prescribing information ↗Supplement approval letter for four NDAs
The FDA letter identifies NDA 050542, 050754, 050760 and 050761 with their corresponding AMOXIL products in the brand regulatory record.
FDA: AMOXIL supplement approval letter for four NDAs ↗AMOXIL brand label revised
The FDA brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension, and 125/200/250/400 mg chewables.
FDA: AMOXIL brand prescribing information ↗NDA/ANDA separation and package comparison reviewed
The current DailyMed AMOXICILLIN capsule/suspension record was confirmed as a separate ANDA label. Eight exact bottle panels are displayed only in a separate comparison section and are not used as AMOXIL NDA package, form or strength evidence.
DailyMed: separate AMOXICILLIN ANDA label ↗
MARKET SCOPE
Market-record boundary
U.S. AMOXIL NDA
Brand label and Orange Book status reviewedIn the imported Orange Book snapshot, most AMOXIL NDA products are DISCN; the 400 mg/5 mL suspension is listed RX, RLD and AB. Status does not establish stock or individual availability.
Separate U.S. ANDA
Retained as a different-product comparatorThe current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension label is not merged into the AMOXIL NDA cards.
Mainland China
‘阿莫仙’ is a search cue onlyNo verified current NMPA brand label and approval relationship has been established; no equivalence, availability or originator conclusion is made.
EU, Japan and other markets
Market record not establishedBrand, dosage form, pack and current status each require independent verification.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
RECORD FAQ
Record questions
Does “amoxicillin” or “500 mg” uniquely identify a product, one dose or a daily total?
No. The 500 mg figure may be the labelled amount in one tablet or capsule; by itself it does not state how many units an individual takes at one time, how often or for how long. Brand, dosage form, strength or concentration, route, market, label version and prescription must be checked together. A generic name or one milligram figure does not replace complete product identity and professional instructions.
Can two 250 mg units directly replace one 500 mg unit, or can a 500 mg tablet replace a 500 mg capsule?
Not from arithmetic alone. An equal milligram total does not establish the same product, dosage form, excipients, administration, packaging, regulatory pathway or prescribing intent. The AMOXIL brand tablets, suspension and chewables on this page and the separate AMOXICILLIN ANDA capsule/suspension label are different product records. Do not self-combine unit counts or change form or manufacturer; take the actual pack and prescription to a pharmacist or prescriber.
Can an amoxicillin capsule be opened, a tablet split, or the medicine mixed with food?
Do not decide from the words “capsule” or “tablet” or from a score mark. Opening, splitting, chewing, mixing or changing to a liquid depends on the exact product and current label. The score on an AMOXIL 875 mg tablet is an identity feature of that product, not universal permission to split it. Ask a pharmacist to review the actual pack, dosage form, label and prescribing purpose, especially for children, people with swallowing difficulty or anyone who needs a precisely measured liquid.
Can AMOXIL, AUGMENTIN, a cephalosporin or another antibacterial be alternated, combined or supplemented with leftovers?
Not from similar names, a shared infection context or past experience. AUGMENTIN also contains clavulanate and is a different product; cephalosporins and other antibacterials have their own ingredients, allergy, interaction and use boundaries. Do not borrow, combine, alternate, make up doses or self-extend a course. A clinician should use the diagnosis, any necessary tests, allergy history, kidney function and complete medicine list, and leftover antibacterials should be handled under local guidance.
Can an older adult, a person with reduced kidney function or someone taking many medicines self-reduce, use alternate days or change to a lower strength?
No. Age alone does not determine an amount, and the FDA label also notes that amoxicillin is substantially excreted by the kidney and adverse-reaction risk may be greater with impaired renal function. Take every pack, the prescription, allergy history, recent kidney-function information and the complete medicine list to the prescriber or pharmacist. Do not self-reduce, use alternate days, change strength or abruptly stop. Breathing difficulty, swelling of the face, lips or tongue, fainting or severe altered awareness requires immediate local emergency care.
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Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.