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← See all NIGHTTIME SLEEP AID Maximum Strength brands

NIGHTTIME SLEEP AID Maximum Strength

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: EQUATE (Walmart Stores, Inc.)
NDC Code: 49035-237

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.

Nighttime Sleep-Aid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses
  • for the relief of occasional sleeplessness

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 persists 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
  • adults and children 12 years of age and over: take 1 softgel (50 mg) at bedtime if needed, or as directed by adoctor

Other information
  • store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-287-1915

PRINCIPAL DISPLAY PANEL 

Nighttime Sleep-Aid
Maximum Strength

Diphenhydramine HCl, 50 mg

Compare to Unisom® SleepGels® Active Ingredient*

32 Softgels

NDC 49035-237-16

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels® 

PRINCIPAL DISPLAY PANEL

Nighttime Sleep-Aid

Maximum Strength

Diphenhydramine HCl, 50 mg

Compare to Unisom® SleepGels® Active Ingredient*

96 Softgels

NDC 49035-237-96

Distributed by: Wal-Mart Stores, Inc.
Bentonville, AR 72716

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

NIGHTTIME SLEEP AID MAXIMUM STRENGTH 
diphenhydramine hydrochloride 50 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-237
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorblueScoreno score
ShapeCAPSULE (oblong) Size13mm
FlavorImprint CodePC5
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-237-161 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
132 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
2NDC:49035-237-9696 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/31/2013
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287MANUFACTURE(49035-237), ANALYSIS(49035-237)

 
EQUATE (Walmart Stores, Inc.)

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Medically reviewed on Feb 9, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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