Major 44-015
3a976e90-c6af-4414-984e-9987158c9e98
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Diphenhydramine HCl 12.5 mg
Purpose
Antihistamine
Medication Information
Purpose
Antihistamine
Description
Diphenhydramine HCl 12.5 mg
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
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 |
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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 0904-7533-15
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
16 FL OZ
(473 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 REV0724A01521
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
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.
Active Ingredient (in Each 5 Ml)
Diphenhydramine HCl 12.5 mg
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.
Structured Label Content
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
Purpose
Antihistamine
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 |
Do Not Use (Do not use)
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Other Information (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 (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? (Questions or comments?)
1-800-426-9391
Principal Display Panel (Principal display panel)
MAJOR®
NDC 0904-7533-15
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
16 FL OZ
(473 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 REV0724A01521
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
When Using This Product (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. (Keep out of reach of children.)
In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Diphenhydramine HCl 12.5 mg
Ask A Doctor Before Use If the Child Has (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 (Ask a doctor or pharmacist before use if the child is)
taking sedatives or tranquilizers.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:41.575285 · Updated: 2026-03-14T23:14:06.332069