DISCOUNT DRUGMART NIGHTTIME SLEEP-AID- diphenhydramine hcl capsule, liquid filled 
Discount Drug Mart, Inc

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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NIGHTTIME SLEEP-AID

Active ingredient

(in each softgel)

Diphenhydramine HCI 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

Inactive ingredients

FD&C Blue No. 1, Gelatin, Glycerine, Polyethylene Glycol, Sorbitol.

PRINCIPAL DISPLAY PANEL

Nighttime Sleep-Aid

DISCOUNT DRUGMART NIGHTTIME SLEEP-AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-822
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)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize13mm
FlavorImprint Code A99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-822-641 in 1 CARTON09/15/2021
164 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33809/15/2021
Labeler - Discount Drug Mart, Inc (047741335)
Registrant - Reese Pharmaceutical Co (004172052)

Revised: 12/2022
Document Id: 64214cba-1b9e-4cb6-af60-9f382e1d4b79
Set id: d6d77c2e-42b3-48f0-a662-3872155ef34d
Version: 3
Effective Time: 20221228
 
Discount Drug Mart, Inc