Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5 mg
Childrens Allergy Relief Solution
FDA Label NDC 63941-505
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Best Choice for the product Childrens Allergy Relief (NDC 63941-505). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antihistamine
Indications & Usage
Uses
temporarily relieves these symptoms due to hay fever or other respiratory allergies:
■ sneezing
■ itching of the nose or throat
■ runny nose
■ itchy watery eyes
■temporarily relieves these symptoms due to the common cold:
■ sneezing
■ runny nose
Warnings
Warnings
Do not use
■ with any other product containing diphenhydramine, even one used on skin
■ to make a child sleepy
Ask a doctor before use if the child has
■ glaucoma
■ a breathing problem such as chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquillizers
Otc - When Using
When using this product
■ marked drowsiness may occur
■ excitability may occur, especially in children
■ sedatives and tranquilizers may increase drowsiness
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)
Dosage & Administration
Directions
■ if needed, take every 4-6 hours
■ do not take more than 6 doses in 24-hours
| children under 4 years of age | Do not use |
| children 4 to under 6 years of age | Do not use unless directed by a doctor |
| children 6 to under 12 years of age | 1 to 2 teaspoonfuls (5 ml to 10 ml) |
Other Safety Information
Other information
■ Keep carton for full directions for use
■ Each teaspoonful contains: sodium 10 mg
■ store at 20 - 25° C (68 - 77" F)
■ dosage cup provided
Inactive Ingredient
Inactive ingredients
citric acid, D&C red # 33, FD&C Red #40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium
chloride, sodium citrate, sucrose
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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Product Label: Best Choice® Children's Allergy Relief
Best Choice®
Children's Allergy Relief
Diphenhydramine HCl
Oral Solution
Antihistamine
Cherry Flavor
8 FL OZ (237 mL)
* This product is not manufactured or distributed by McNeil PPC, Inc., distributor of Benadryl® Allergy Liquid.
PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.
5000 KANSAS AVE, KANSAS CITY, KS 66106
Carton
Bottle
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* Please review the disclaimer below.
