SLEEP AID NIGHTTIME- diphenhydramine hcl capsule 
EQUALINE (SuperValu)

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

Uses

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

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

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, polyethylene glycol, propylene glycol*, purified water, sorbitol-sorbitan

*contain one or more of these ingredient

Questions or comments?

Call toll free 1-877-932-7948

Principal Display Panel

Compare to Unisom® SleepGels® active ingredient**

maximum strength

Sleep-Aid softgels

diphenhydramine HCl, 50 mg

(nighttime Sleep-Aid)

liquid filled

softgels

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY SUPERVALU INC, EDEN PRAIRIE, MN 55344 USA

Product Label

Diphenhydramine HCI 50 mg

EQUALINE Sleep-Aid Softgels

SLEEP AID  NIGHTTIME
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-734
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99;D50;AP018
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-734-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/201812/27/2024
2NDC:41163-734-321 in 1 BOX12/31/201812/27/2024
232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33812/31/201812/27/2024
Labeler - EQUALINE (SuperValu) (006961411)

Revised: 9/2022
Document Id: c77abd1f-fd9c-4f2d-89ed-3c556de7f7de
Set id: 83f489f0-bf6d-4e15-a1f3-4856678cb3f5
Version: 3
Effective Time: 20220926
 
EQUALINE (SuperValu)