ALLERGY- diphenhydramine hydrochloride tablet 
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

(in each tablet)

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

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

Questions or Comments

Call 1-855-314-1850

READ AND KEEP CARTON FOR COMPLETE WARNING AND INFORMATION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

a73713d3-figure-01
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NDC 70677-0009-1

ALLERGY 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0009
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code EL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-0009-1100 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: a73713d3-5fb8-4d42-80e8-8d8feceb3b8c
Set id: 046f3426-802d-491b-9c12-4ee711898f6b
Version: 1
Effective Time: 20161213
 
Mckesson