DIPHENHYDRAMINE HCL- diphenhydramine hcl capsule 
A-S Medication Solutions

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCL 25 mg

Purpose

Antihistamine

Uses:

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies.

Warnings:

Do not use

Ask a doctor or pharmacist before use

If you have

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:

Adults and children 12 years or over1 to 2 capsule                                     
Children 6 to under 12 years1 capsule
Children under 6 yearsask a doctor

Other information:

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

HOW SUPPLIED

Product: 50090-5716

NDC: 50090-5716-0 30 CAPSULE in a BOTTLE

NDC: 50090-5716-3 20 CAPSULE in a BOTTLE

DIPHENHYDRAMINE HCL

Label Image
DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5716(NDC:66424-020)
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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code PH014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-5716-030 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
2NDC:50090-5716-320 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/27/2010
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-5716) , REPACK(50090-5716)

Revised: 12/2023
Document Id: 96bb0a7a-9a5e-4232-aa2d-f52196784f71
Set id: 5767f546-a751-4583-a8b7-971175c27ef0
Version: 6
Effective Time: 20231204
 
A-S Medication Solutions