FDA Label for Childrens Loratadine
View Indications, Usage & Precautions
- OTHER
- 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
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 5 MG TABLET BLISTER PACK CARTON
Childrens Loratadine Product Label
The following document was submitted to the FDA by the labeler of this product Safeway. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA
94566-0009
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?
call 1-800-406-7984
Principal Display Panel - 5 Mg Tablet Blister Pack Carton
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Quality
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Compare to
Children's Claritin® Chewables
active ingredient†
NDC 21130-999-20
24 Hour | Non-Drowsy*
Children's Allergy Relief
AGES 2 YEARS & OLDER
LORATADINE CHEWABLE TABLETS USP, 5 mg Antihistamine
GRAPE FLAVOR
Actual Size
- Indoor & outdoor allergies
- Relief of: Sneezing; runny nose; itchy, watery eyes; itchy throat or nose
*When taken as directed. See Drug Facts Panel.
The chewable tablets are to be chewed before swallowing.
20 CHEWABLE
TABLETS
* Please review the disclaimer below.