SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule, liquid filled 
EQUATE (Wal-Mart Stores, 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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Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for 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 a 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

  • store at 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Unisom® SleepGels® Active Ingredient†

Maximum Strength

Nighttime Sleep Aid

Diphenhydramine HCl 50 mg

Safe and Non-Habit Forming

• Get to sleep fast  •  Sleep soundly   •  Wake refreshed

LiquidCaps

One Softgel Per Dose

LIQUID-FILLED SOFTGELS

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®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Diphenhydramine HCl 50 mg

Equate Maximum Strength Nighttime Sleep Aid Softgel

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-236
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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P50;A99;S90
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-236-321 in 1 BOX02/01/201403/01/2020
132 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49035-236-9696 in 1 BOTTLE; Type 0: Not a Combination Product02/01/201403/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/01/201403/01/2020
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 12/2018
Document Id: 09144e70-3906-4e5f-9052-2d2450d512f8
Set id: c6a0227b-f8c4-4e0c-87de-f44eec9d96cd
Version: 4
Effective Time: 20181205
 
EQUATE (Wal-Mart Stores, Inc.)