SLEEP AID- diphenhydramine hcl capsule 
The Kroger Co.

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

*may contain this ingredient

Questions or comments?

Call 1-800-632-6900

Principal Display Panel

**COMPARE TO the active ingredient in UNISOM® SLEEPGELS® **See back panel

MAXIMUM STRENGTH

Sleep-Aid Softgels

Diphenhydramine HCI, 50 mg

Nighttime Sleep Aid

Safe, Non-Habit Forming

SOFTGELS

ONE SOFTGELS PER DOSE

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

**UNISOM® SLEEPGELS® IS A REGISTERED TRADEMARK OF CHATTEM, INC., CHATTANOOGA, TN 37409. CHATTEM,INC., IS NOT AFFILIATED WITH THE KROGER CO. OR THIS PRODUCT.

DISTRIBUTED BY: THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

Package Label

Diphenhydramine HCI 50 mg

KROGER Sleep-Aid Softgels

SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-835
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)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code P50;A99;AP018
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-835-9696 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201812/27/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/30/201812/27/2024
Labeler - The Kroger Co. (006999528)

Revised: 9/2022
Document Id: c237eeb1-b6d7-49b6-acdf-34dea65b6484
Set id: 9d508560-532e-4e2b-a925-e91537df0b7a
Version: 5
Effective Time: 20220926
 
The Kroger Co.