Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Allergy Relief Tablet, Chewable
FDA Label NDC 46122-425
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Allergy Relief (NDC 46122-425). 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 (1-800-222-1222) right away.
Directions
- find right dose on chart below
- 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
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions Or Comments?
1-800-426-9391
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Good Neighbor Pharmacy®
Compare to Children's Benadryl®
Chewables active ingredient*
NDC 46122-425-89
For Ages 6-11
CHILDREN'S
Allergy Relief
diphenhydramine HCl 12.5 mg
Antihistamine
Relief of:
•Sneezing • Runny Nose
•Itchy Throat • Itchy, Watery Eyes
Cherry Flavor
Chewables
20 Tablets ι 12.5 mg Each
Actual Size
Distributed By
AmerisourceBergan
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Children's Benadryl® Chewables.
50844 ORG031759909
GOOD NEIGHBOR PHARMACY
BRAND PRODUCTS
SATISFACTION GUARANTEED
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
Good Neighbor Pharmacy 44-599 (Good Neighbor Pharmacy 44 599 1) 
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