MAXIMUM STRENGTH NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
PuraCap Pharmaceutical LLC

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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MAXIMUM STRENGTH Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product avoid alcoholic drinks

Stop use and ask a doctor if sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

Other information

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

Questions or comments?

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

MARKET BASKET MAXIMUM STRENGTH Nighttime Sleep-Aid

32 SOFTGELS

NDC 51013-179-16

*Compare to the active ingredient in Unisom® SleepGels®

Carton Label

Bottle Label

MAXIMUM STRENGTH NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-179
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorblue (clear) Scoreno score
Shapecapsule (oval) Size13mm
FlavorImprint Code PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-179-161 in 1 CARTON07/12/2016
132 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33807/12/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-179) , analysis(51013-179)

Revised: 1/2020
Document Id: 518b94dd-2b8b-4c42-ba6b-3ed2ddd3d196
Set id: b13970a6-85ee-46a0-85de-08bb1fe0b3d9
Version: 2
Effective Time: 20200102
 
PuraCap Pharmaceutical LLC