Active Ingredient (In Each Tablet)
Diphenhydramine HCl 12.5 mg
Allergy Relief Tablet, Chewable
FDA Label NDC 41163-585
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Allergy Relief (NDC 41163-585). 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 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
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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 in 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 |
| children 6 to 11 years | 1 to 2 chewable tablets (12.5 mg to 25 mg) |
adults and children 12 years | 2 to 4 chewable tablets (25 mg to 50 mg) |
Other Information
- avoid high humidity
- 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)
- 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 Or Comments?
1-877-932-7948
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EQUALINE®
compare to
Children's Benadryl®
Chewables
active ingredient*
NDC 41163-585-44
children's
allergy relief
diphenhydramine HCl 12.5 mg
(antihistamine)
for ages 6-11
chewable
grape flavor
relieves:
• sneezing • itchy throat
• runny nose • itchy, watery eyes
18 tablets
actual size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children's Benadryl® chewables.
50844 REV0317A58544
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EDEN PRAIRIE, MN 55344 USA
Equaline 44-585 (Equaline 44 585 1) 
* Please review the disclaimer below.
