DIPHENHYDRAMINE HCL - diphenhydramine hcl 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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Drug Facts

Active Ingredient

(in each capsule)

Diphenhydramine HCl 25mg

Purpose

Sleep Aid

Uses

Warnings

Do not use

Ask a doctor before use if you have:

Keep out of reach of children.

Overdose Warning: Taking more than directed can cause serious health problems, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Take only one dose per day (24 hours)- see Overdose warning.

Adults and Children 12 years and over

Other Information

Inactive Ingredients

FD&C Blue No. 1, FD&C Red No. 40, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol, Titanium Dioxide

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: This Package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

108b7ac2-figure-01

NDC: 58805-001-14 LIQUID GELS

DIPHENHYDRAMINE HCL 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58805-001
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code 602
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58805-001-143600 in 1 BLISTER PACK
11 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/2013
Labeler - Agile Pharmachem (650687853)
Registrant - Agile Pharmachem (650687853)

Revised: 2/2014
Document Id: 108b7ac2-082d-47d4-a07d-58c50e40bb5c
Set id: 92445b53-cd51-4bc8-9db9-cbc9d3ea9d4c
Version: 1
Effective Time: 20140216
 
Agile Pharmachem