Otc - Active Ingredient
Drug Facts
Active ingredient
(in each 5 mL teaspoon)
Diphenhydramine HCL 12.5 mg
Childrens Allergy Liquid
FDA Label NDC 76281-505
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Childrens Allergy (NDC 76281-505). 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, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, 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
Otc - Ask Doctor
Ask a doctor before use if the child has
■ glaucoma
■ abreathing problem such as chronic bronchitis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the
child is taking sedatives or tranquilizers
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.
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 (12.5 mg to 25 mg) |
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 or comments? Call weekdays
from 9:30 AM to 4:30 PM EST at 1-877-798-5944.
Product Label
AP SAFE NDC 72681-505-24
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S BENADRYL®
ALLERGY LIQUID*
Children's
Allergy
Relief
DIPHENHYDRAMINE HCl
Liquid
Antihistamine
Relieves: Sneezing,
Runny Nose,
Itchy Watery Eyes,
Itchy Throat
• Alcohol-Free
4 FL OZ (118 mL) Cherry Flavor
DO NOT USE IF PRINTED SEAL
UNDER CAP IS TORN OR MISSING
2
1013430
3/20
*This product is not manufactured or
distributed by McNeil PPC, Inc., distributor
of Benadryl® Allergy liquid.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
AP-BX-03
Carton
Bottle
res
* Please review the disclaimer below.
