Active Ingredient (In Each Tablet)
Loratadine 5 mg
Claritin Chewable Grape And Bubblegum Kit
FDA Label NDC 11523-0123
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 Chewable Grape And Bubblegum (NDC 11523-0123). 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 tablet), 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
- chew or crush tablets completely before swallowing.
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 chewable tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 chewable tablet in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
phenylketonurics:
- grape flavor contains phenylalanine 1.4 mg per chewable tablet
- bubblegum flavor contains phenylalanine 1.9 mg per chewable tablet
safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
Grape chewable tablets
aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic aicd
Bubblegum chewable tablets
aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-CLARITIN (1-800-252-7484)
Principal Display Panel - 40 Chewable Tablet Blister Pack Carton
VARIETY PACK
ages
2 +
years
Non-Drowsy*
Children's
Claritin ®
Chewables
loratadine chewable tablets
5 mg/antihistamine
24 Hour
Non-Drowsy* Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
20 Grape Flavored
20 Bubblegum Flavored
*When taken as directed. See Drug Facts Panel.
40 CHEWABLE TABLETS
* Please review the disclaimer below.
