Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Childrens Allergy Relief Tablet, Chewable
FDA Label NDC 0363-4808
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Childrens Allergy Relief (NDC 0363-4808). 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 active ingredient (in each chewable tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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 You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
- excitability may occur, especially in children
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- find right dose on chart below
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
| Age (yr) | Dose (chewable tablets) |
| children under 2 years | do not use |
| children 2 to 5 years | do not use unless directed by a doctor |
| children 6 to 11 years | 1 to 2 chewable tablets (12.5 mg to 25 mg) |
| adults and children 12 years and over | 2 to 4 chewable tablets (25 mg to 50 mg) |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
Inactive Ingredients
dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 0363-4808-09
Walgreens
Compare to the active ingredient in
Children’s Benadryl® Chewables††
WALGREENS PHARMACIST RECOMMENDED†
Children’s
Allergy Relief
DIPHENHYDRAMINE HCl, 12.5 mg /
CHEWABLE TABLETS / ANTIHISTAMINE
Dye Free 4-6 Hour Dose
• Relieves itchy or runny nose,
sneezing, itchy throat &
itchy, watery eyes
AGES
6
YEARS &
OLDER
ACTUAL SIZE
Cherry
flavor
20 CHEWABLE
TABLETS
CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.
DO NOT SWALLOW TABLETS WHOLE.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the
registered trademark Children’s
Benadryl® Chewables.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2021 Walgreen Co.
50844 ORG121848009
Walgreens 44-481 (Walgreens 44 481 Childrens Allergy Relief 1)
* Please review the disclaimer below.
