Active Ingredient (In Each 5 Ml Teaspoonful)
Loratadine 5 mg
Claritin Solution
FDA Label NDC 11523-0101
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 11523-0101). 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 active ingredient (in each 5 ml teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- 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.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Directions
- use only with enclosed dosing cup
- mL = milliliter
Adults and children 6 years and over: 10 mL daily, do not take more than 10mL in 24 hours; children 2 to under 6 years of age: 5mL daily, do not take more than 5mL in 24 hours; children under 2 years of age: ask a doctor
Other Information
- each 5 mL contains: sodium 5.5 mg
- do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredient
edetate disodium, flavors, glycerin, maltitol, menthol, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose
Questions Or Comments?
1-800-CLARITIN (1-800-252-7484)
* Please review the disclaimer below.
