What this pack is
CLARINEX is the brand name in this record; desloratadine tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
CLARINEXGeneric namedesloratadine tablets
How this medicine works
The label describes desloratadine as a long-acting H1-receptor antagonist and the major active metabolite of loratadine. This helps explain an allergy pathway but does not prove symptoms are allergic or create milligram conversion, combination or rotation rules with loratadine, cetirizine, levocetirizine, fexofenadine or diphenhydramine.
Read source: United States ↗Current regulatory record · reviewed 2026-09-03More 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.
- International brand name
- CLARINEX
- Source-scoped market brand names
- CLARINEX · U.S. prescription brandCurrent regulator record ↗NDA 021165; current public packs are 5 mg immediate-release tablets in 100-tablet bottles.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- desloratadine tablets
- Dosage-form class
- Immediate-release film-coated oral tablets. Five mg is the amount of desloratadine in each tablet, while 100 is the number of tablets in the bottle; the figures must not be multiplied or turned into an individual's daily tablet count. Oral-solution concentration, orally disintegrating tablets and pseudoephedrine-containing CLARINEX-D are separate product identities and must not be combined arithmetically.
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
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.
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.
2 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 U.S. prescription brand label (SPL v6, published 28 May 2025)
Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle
- Product code
- NDC 78206-119-01
- Form and route
- CLARINEX desloratadine immediate-release film-coated tablet · oral
- Container
- high-density polyethylene bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- desloratadine
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency or course
- Package
- 100 tablets per bottle
- Labelled appearance
- light blue · round film-coated tablet, not scored · imprint C5Not scored in this labelled presentation
United States label · Current U.S. prescription brand label (SPL v6, published 28 May 2025)
Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle
- Product code
- NDC 78206-188-01
- Form and route
- CLARINEX desloratadine immediate-release film-coated tablet · oral
- Container
- high-density polyethylene bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- desloratadine
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency or course
- Package
- 100 tablets per bottle
- Labelled appearance
- light blue · round film-coated tablet, not scored · imprint SPNot scored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
CLARINEX enlarged label: 5 mg, 100 tablets, sleepiness, liver/kidney function and duplicate antihistamines
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.
Five mg is the amount in one tablet and 100 is the number of tablets in the bottle, not an individual's daily count. The current U.S. brand label displays only immediate-release tablets; the brand oral solution and orally disintegrating tablets remain in clinical text but are no longer marketed. The site explains exact-product and safety questions without calculating individual frequency, course, taper or switching.
- Both current bottles contain 5 mg per tablet and 100 tablets, but their NDCs and imprints differ: 78206-119-01 is C5 and 78206-188-01 is SP. A similar name or colour cannot replace a complete check of NDC, dosage form, strength, pack and label date.
- The label states that adults with hepatic or renal impairment need a different starting arrangement. This page does not convert that text into an individual alternate-day, half-tablet or stopping instruction; older adults and people with liver or kidney problems need the exact product, clinical information and complete medicine list reviewed by a clinician or pharmacist.
- The label includes fatigue, sleepiness and dizziness and asks patients to disclose prescription medicines, nonprescription medicines, vitamins and herbs. Older adults and people using multiple medicines should review falls, driving and duplicate-antihistamine risks rather than assume self-spacing removes combined effects.
- Rash, hives, swelling of the face, lips, tongue or throat, and breathing difficulty can signal a serious hypersensitivity reaction. Breathing difficulty or facial, tongue or throat swelling requires local emergency help; website search cannot replace emergency care.
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 checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-03
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 · 1
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 routeDailyMed (NLM): current U.S. prescription label for CLARINEX desloratadine 5 mg film-coated tablets (SPL v6, published 28 May 2025) ↗Current regulatory record · reviewed 2026-09-03
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →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 CLARINEX (desloratadine tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
CLARINEX is the brand in this record and desloratadine tablets is the active-ingredient name. Check both with the dosage form (Immediate-release film-coated oral tablets. Five mg is the amount of desloratadine in each tablet, while 100 is the number of tablets in the bottle; the figures must not be multiplied or turned into an individual's daily tablet count. Oral-solution concentration, orally disintegrating tablets and pseudoephedrine-containing CLARINEX-D are separate product identities and must not be combined arithmetically.) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How desloratadine works: peripheral H1 antagonism does not make antihistamines interchangeable
- CLARINEX and CLARITIN are closely related in name and chemistry but are not the same exact product; being a metabolite does not support home milligram conversion, combination or alternate-day rotation.
- CLARINEX-D 12 HOUR also contains pseudoephedrine and is an extended-release combination tablet; it is not the single-ingredient immediate-release tablet in this dossier. People checking congestion products should compare the full ingredient list rather than treat the combination as ordinary CLARINEX.
- Belonging to the antihistamine class does not make efficacy, adverse effects, liver/kidney handling or dosage forms identical. Persistent or unexplained symptoms need professional review of the diagnosis and complete medicine list rather than self-switching within the class.
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.
- DailyMed (NLM): current U.S. prescription label for CLARINEX desloratadine 5 mg film-coated tablets (SPL v6, published 28 May 2025) ↗Current regulatory record · reviewed 2026-09-03
- FDA: CLARINEX desloratadine tablets, oral solution and RediTabs supplement approval letter (6 May 2014) ↗reviewed 2026-09-03
SOURCE-TRACEABLE ARCHIVE
CLARINEXdesloratadine tablets
This page includes an exact current U.S. public-label package panel for CLARINEX, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
U.S. approval of CLARINEX 5 mg tablets
FDA materials link NDA 021165 to the initial approval of 5 mg desloratadine tablets.
FDA: CLARINEX desloratadine tablets, oral solution and RediTabs supplement approval letter (6 May 2014) ↗FDA approved multi-formulation labelling updates
The supplement approval covers tablets, oral solution and RediTabs and adds postmarketing movement-disorder wording.
FDA: CLARINEX desloratadine tablets, oral solution and RediTabs supplement approval letter (6 May 2014) ↗Current DailyMed SPL v6 published
The current record displays two 5 mg, 100-tablet bottles and says the brand oral solution and orally disintegrating tablets are no longer marketed.
DailyMed (NLM): current U.S. prescription label for CLARINEX desloratadine 5 mg film-coated tablets (SPL v6, published 28 May 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current public brand prescription-tablet labelNDA 021165; 5 mg immediate-release tablets in two 100-tablet bottle NDCs.
Other U.S. brand dosage forms
Oral solution and RediTabs no longer marketedClinical text remains visible but does not establish current brand availability.
Outside the United States
Local products not established in this dossierCheck the local regulator and the pack in hand.
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
What do 5 mg and 100 tablets mean?
Five mg is the amount of desloratadine in each tablet; 100 tablets is the count in the bottle. These are product-identity fields, not an individual's daily count, frequency or course.
Can it be taken with Claritin, XYZAL, ZYRTEC or a cold medicine?
A website cannot make that decision. Many prescription and OTC cold/allergy products duplicate antihistamines or add sedation; give a pharmacist or clinician the full ingredient lists from every actual pack and the complete medicine list.
Does an imprint other than C5 mean counterfeit?
No. The current official label itself lists both C5 and SP imprints with different NDCs, and other manufacturers or markets may differ. Website images and OCR cannot authenticate a medicine; use a pharmacist, authorised supply chain and local regulator.
READ NEXT
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.