SLEEP AID- diphenhydramine hcl capsule 
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-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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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. (1-800-222-1222)

Directions

Other information

Inactive ingredients

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

*may contain this ingredient

Principal Display Panel

Compare to Unisom® SleepGels® Active Ingredient**

Maximum Strength

Sleep-Aid Softgels

Diphenhydramine HCI 50 mg

Nighttime sleep-aid

Liquid Filled

Safe, Non Habit-Forming

One softgel per dose

SOFTGELS

For Questions or comments or to report an undesired reactionor side effect, please call 1-888-287-1915.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

**This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

Package Label

Diphenhydramine HCI 50 mg

EQUATE Maximum Strength Sleep-Aid Softgels

SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-935
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
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99;AP018
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-935-321 in 1 BOX02/28/201812/27/2024
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:49035-935-10100 in 1 BOTTLE; Type 0: Not a Combination Product02/28/201812/27/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/28/201812/27/2024
Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769)

Revised: 9/2022
Document Id: d7d59113-ba37-431c-950a-39ef82307131
Set id: f1bf058a-b2e4-44d7-99d7-55013e2c692d
Version: 4
Effective Time: 20220927
 
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)