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Drug Facts
Claritin Tablet
FDA Label NDC 11523-0800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Claritin (NDC 11523-0800). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, uses, otc - do not use, ask a doctor, when using this product, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each tablet)
Loratadine, 10 mg USP
Otc - Purpose
Purpose
Antihistamine
Uses
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
■ runny nose ■ sneezing
■ itchy, watery eyes ■ itching of the nose or throat
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask A Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When Using This Product
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
Directions
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
■ store at 20° -25° C (68° -77° F) (see USP Controlled Room Temperature)
Inactive Ingredient
Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Otc - Questions
Questions or comments?
1-800-CLARITIN (1-800-252-7484) or www.claritin.com
Carton Label 10 Count Tablets
Original Prescription Strength
Non-Drowsy*
Claritin®
loratadine tablets 10 mg/antihistamine
Indoor & Outdoor
Allergies
24
Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*When taken as directed.
See Drug Facts Panel
* Please review the disclaimer below.
