Other
Drug Facts
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011
Childrens Allergy Relief
FDA Label NDC 11822-0098
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Childrens Allergy Relief (NDC 11822-0098). 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 5 ml teaspoonful), purpose, uses, otc - do not use, otc - ask doctor, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml Teaspoonful)
Loratadine 5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- 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.
Stop Use And Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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
| adults and children 6 years and over | 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 20° and 25°C (68° and 77°F)
Inactive Ingredients
artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
Principal Display Panel - 120 Ml Bottle Carton
RITE
AID®
PHARMACY
Compare to the
active ingredient in
Children's Claritin®*
ORIGINAL
PRESCRIPTION
STRENGTH
children's
allergy
relief
loratadine oral solution
5 mg/5 mL antihistamine
fruit flavored oral solution
INDOOR &
OUTDOOR ALLERGIES
NON-DROWSY†
DYE FREE
24 hour relief of:
sneezing & runny nose
itchy, watery eyes
itchy throat or nose
2 years & older
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
Principal Display Panel (120 mL Bottle Carton)
* Please review the disclaimer below.
