DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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0835K- Major

Drug Facts

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

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

 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
 trouble urinating due to an enlarged 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 drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful 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 (1-800-222-1222).

Directions

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children
12 years of age and over
1 to 2 capsules
children 6 to
under 12 years of age
1 capsule
children under 6 years of agedo not use this product
in children under 6 years of age

Other information

 store in a dry place at 15° – 30°C (59° – 86°F)

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Questions or comments?

1-800-616-2471

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

To preserve quality and freshness, keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

Major

BENOPHEN

NDC 0904-7237-80

Complete Allergy Medication

Diphenhydramin HCl 25 mg

Antihistamine

For the temporary relief of the symptoms of:
• Upper Respiratory Allergies

• Hay Fever

Compare to the active ingredient in BENADRYL®*

1000 CAPSULES

EACH CAPSULE INDIVIDUALLY
BANDED FOR YOUR PROTECTION

Major Label

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7237
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (Half pink and half clear with white powder inside and sealed with red band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7237-801000 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2022
2NDC:0904-7237-60100 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2022
3NDC:0904-7237-242 in 1 CARTON04/14/2022
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0904-7237-6110 in 1 BOX, UNIT-DOSE04/14/2022
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/14/2022
Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2022
Document Id: dca04d80-e782-40b1-e053-2995a90a7010
Set id: dca04d80-e781-40b1-e053-2995a90a7010
Version: 1
Effective Time: 20220414
 
Major Pharmaceuticals