ALLERGY- diphenhydramine hydrochloride capsule 
Mckesson

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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DIPHENHYDRAMINE HCl 25mg, USP

Active Ingredient

(per capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

Warnings

Do not 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

Other Information

Inactive Ingredients

Benzyl alcohol, Butyl paraben, D&C red # 28, FD&C blue # 1, FD&C  red # 40, Edible black ink, gelatin, lactose, Magnesium stearate, Methyl paraben, polysorbate 80, Propyl paraben, Purified water, Sodium lauryl sulfate, Starch

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4cc94678-figure-01
4cc94678-figure-02

NDC 70677-0010-1

ALLERGY 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0010
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize14mm
FlavorImprint Code AP;020
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-0010-1100 in 1 BOTTLE11/25/2016
11 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/25/2016
Labeler - Mckesson (177667227)

Revised: 12/2016
Document Id: 4cc94678-3221-40f1-b068-d133fd59eb5b
Set id: d8c2dc53-7fbd-461c-b0c8-dac14a5d995a
Version: 1
Effective Time: 20161217
 
Mckesson