Other
Drug Facts
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Dye-free Childrens Loratadine Tablet, Chewable
FDA Label NDC 51316-821
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Dye-free Childrens Loratadine (NDC 51316-821). 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, active ingredient (in each chewable tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Chewable Tablet)
Loratadine USP, 5 mg
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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Otc - Stop Use
Stop use and ask a doctor ifan 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 (1-800-222-1222).
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: contains phenylalanine 1.25 mg per tablet.
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25°C (68° to 77°F).
Inactive Ingredients
aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.
Principal Display Panel - 5 Mg Tablet Blister Pack Carton
CVS
Health
®
Compare to the active ingredient in
Children's Claritin
®Chewables
†
Indoor & Outdoor Allergies
NDC 51316-821-20
Children's
Allergy Relief
LORATADINE CHEWABLE
TABLETS USP, 5 mg
Antihistamine
Non-Drowsy*
- 24 hour relief of:
Sneezing; Runny nose; Itchy,
watery eyes; Itchy throat or nose - Ages 2+ years
- Dye free
*When taken as directed.
See Drug Facts Panel
Actual
Size
Grape
Flavor
20 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.
24
HOUR
20ct (Cvs 20ct)
* Please review the disclaimer below.
