NIGHTIME SLEEP AID - diphenhydramine capsule, liquid filled 
Agile Pharmachem

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 50mg, USP

Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Uses

Directions

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)

Other Information

Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8a592765-figure-01
8a592765-figure-02

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-00  Softgel Liquid filled

NIGHTIME SLEEP AID 
diphenhydramine capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SORBITOL (UNII: 506T60A25R)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize16mm
FlavorImprint Code 206
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58805-006-00750 in 1 BOX
11 in 1 BAG
2NDC:58805-006-01750 in 1 BOX
230 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2014
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

Revised: 3/2015
Document Id: 8a592765-a0be-417d-9ca5-ba530235a986
Set id: 114b71f9-36b1-4372-805e-65cbb61f2925
Version: 2
Effective Time: 20150331
 
Agile Pharmachem