Active Ingredient (In Each 5 Ml)
Diphenhydramine HCl 12.5 mg
Allergy Relief Solution
FDA Label NDC 0904-7533
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Allergy Relief (NDC 0904-7533). 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 5 ml), purpose, uses, do not use, ask a doctor before use if the child has, ask a doctor or pharmacist before use if the child is, when using this product, 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
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- 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 The Child Has
- glaucoma
- a breathing problem such as chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If The Child Is
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
- excitability may occur, especially in children
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- do not take more than 6 doses in 24 hours
- mL = milliliter
- only use the dose cup provided
- find right dose on chart below
- take every 4 to 6 hours, or as directed by a doctor
| Age (yr) | Dose (mL) |
| 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 | 5 mL to 10 mL |
Other Information
- each 5 mL contains: sodium 4 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- protect from light
Inactive Ingredients
anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucrose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
MAJOR®
NDC 0904-7533-20
compare to the active ingredient in
Children’s Benadryl® Allergy*
children’s
allergy relief
diphenhydramine HCl,
12.5 mg per 5 mL
oral solution
antihistamine
relieves:
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat or nose
ages 6 to
11 years
cherry flavored
alcohol free
4 FL OZ
(118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Children’s Benadryl® Allergy.
50844 ORG072401536
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Major 44-015 (Major 44 015 1)
* Please review the disclaimer below.
