Other
Drug Facts
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Loratadine Tablet, Chewable
FDA Label NDC 0363-9985
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Loratadine (NDC 0363-9985). 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-30 Count
NDC 0363-9985-30
Walgreens
Compare to the active ingredient
in Children's Claritin
®Chewables
††
• WALGREENS •
PHARMACIST RECOMMENDED
†
Children's
Allergy Relief
LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE
Dye Free
Non-Drowsy*
24-Hour Relief
- 24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
- Indoor & outdoor allergies
AGES
2+
YEARS
30 CHEWABLE TABLETS
Chewable tablets are to be chewed before swallowing.
ACTUAL SIZE
Grape
flavor
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
30ct (Walgreen Grape 30)
Principal Display Panel - 5 Mg Tablet Blister Pack Carton-60 Count
NDC 0363-9985-60
Walgreens
Compare to the active ingredient
in Children's Claritin ®Chewables ††
• WALGREENS •
PHARMACIST RECOMMENDED †
Children's
Allergy Relief
LORATADINE CHEWABLE TABLETS USP, 5 mg / ANTIHISTAMINE
Dye Free
Non-Drowsy*
24-Hour Relief
24-hour relief of sneezing, runny nose, itchy throat or nose, & itchy, watery eyes
Indoor & outdoor allergies
AGES
2+
YEARS
60 CHEWABLE TABLETS
Chewable tablets are to be chewed before swallowing.
ACTUAL SIZE
Grape
flavor
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
Lorat-grape-60 (Lorat Grape 60ct)
* Please review the disclaimer below.
