Active Ingredient (In Each Chewable Tablet)
Diphenhydramine HCl 12.5 mg
Allergy Relief Tablet, Chewable
FDA Label NDC 67091-425
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Allergy Relief (NDC 67091-425). 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, warnings, 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, 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
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 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
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- 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
- 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, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions?
Call 1-800-824-1706 Monday – Friday 9am – 4pm MST
Principal Display Panel
*Compare to the active ingredient in
Children’s BENADRYL® Chewables
WinCo®
FOODS
Allergy Relief
Children's
DIPHENHYDRAMINE HCl 12.5 mg
CHEWABLE TABLETS/ANTIHISTAMINE
Relieves: Sneezing, Runny Nose,
Itchy, Watery Eyes & Itchy Throat or Nose
20
Chewable
Tablets
CHEW OR CRUSH TABLETS
COMPLETELY BEFORE SWALLOWING.
100% SATISFACTION GUARANTEE
Comments & Questions? www.wincofoods.com
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
DISTRIBUTED BY:
WINCO FOODS, LLC,
BOISE, ID 83704
* This product is not manufactured or
distributed by KENVUE INC., owner
of the registered trademark Children’s
BENADRYL® Chewables.
Winco 44-585 (Winco 44 585 Reserved 67091 425 1)
* Please review the disclaimer below.
