0835&0836(box unit)-Major

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
A-S Medication Solutions

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0835&0836(box unit)-Major

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat and nose
  • Temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

50 MG

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy throat and nose

WARNINGS

Do not use

25 MG

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

50 MG

  • to make a child sleepy
  • with any other product containing diphenhydramine, including one applied topically

Ask a doctor before use if you have

25 MG

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

50 MG

  • 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 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.

Directions

  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours

25 MG

adults and children 12 years of age and over1 to 2 capsules
children 6 years to under 12 years of age1 capsule
children under 6 years of agedo not use this product in children under 6 years of age

50 MG

adults and children 12 years of age and over1 capsule
children 6 years to under 12 years of ageAsk a doctor, the proper dosage strength is not available in this package**

**Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

Other Information

  • Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • Protect from moisture
  • Contains lactose

Inactive Ingredients

D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

Questions?

Questions or comments? (800) 616-2471

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

HOW SUPPLIED

Product: 50090-2764

NDC: 50090-2764-0 1 CAPSULE in a BLISTER PACK / 32 in a BOX, UNIT-DOSE

NDC: 50090-2764-1 1 CAPSULE in a BLISTER PACK / 100 in a BOX, UNIT-DOSE

Diphenhydramine Hydrochloride

Label Image
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-2764(NDC: 0904-5306)
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)  
BLUE 1 (UNII: H3R47K3TBD)  
RED 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
ZEA MAYS (CORN) STARCH (UNII: O8232NY3SJ)  
Product Characteristics
Colorpink (half pink and half clear with white powder inside) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code CPC;835
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-2764-032 in 1 BOX, UNIT-DOSE01/06/202501/06/2025
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 50090-2764-1100 in 1 BOX, UNIT-DOSE01/06/202501/06/2025
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/02/200901/06/2025
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-2764) , REPACK(50090-2764)

Revised: 1/2025