DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule 
A-S Medication Solutions

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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0835&0836(box unit)-Major

Active Ingredient (in each banded capsule)

Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg

Purpose

Antihistamine

Use

25 MG

50 MG

WARNINGS

Do not use

25 MG

50 MG

Ask a doctor before use if you have

25 MG

50 MG

Ask a doctor or pharmacist

before use if you are taking sedatives or tranquilizers

When using this product

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

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

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: 50090-3788

NDC: 50090-3788-0 8 CAPSULE in a BOTTLE

NDC: 50090-3788-1 10 CAPSULE in a BOTTLE

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE BANOPHEN (DIPHENHYDRAMINE HCL) CAPSULE

Label Image
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3788(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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (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:50090-3788-08 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2018
2NDC:50090-3788-110 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/02/2009
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-3788) , REPACK(50090-3788)

Revised: 3/2021
Document Id: 52c7eee7-ef39-4b8b-ac02-9f74eb160f40
Set id: 7db1790f-0bbb-4a29-8451-e7208fa43880
Version: 1
Effective Time: 20210301
 
A-S Medication Solutions