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Drug Facts
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Loratadine Tablet, Chewable
FDA Label NDC 49035-953
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc for the product Loratadine (NDC 49035-953). 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 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 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 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 (1-800-222-1222).
Directions
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 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, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
1-888-287-1915
Principal Display Panel - 5 Mg Tablet Blister Pack Carton
NDC 49035-953-30
equate™
Compare to
Children's Claritin®
Chewables active
ingredient*
children★s Non-Drowsy**
LORATADINE CHEWABLE
Tablets USP, 5mg
Antihistamine
24
HOURS
AGES 2 YEARS AND OLDER
Indoor & Outdoor Allergies
Grape Flavored
30 Chewable Tablets
The chewable tablets are to be chewed before swallowing.
Relief of:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
**When taken as directed.
See Drug Facts Panel.
Principal Display Panel (5 mg Tablet Blister Pack Carton)
* Please review the disclaimer below.
