MAXIMUM STRENGTH SLEEP AID- diphenhydramine hcl capsule, gelatin coated 
KROGER COMPANY

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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Kroger® MAXIMUM STRENGTH Sleep Aid Softgels

Drug Facts

Active ingredient (in each softgel)                           

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

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 persist continuosly 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. 1-800-222-1222

Directions

Inactive ingredients

FD&C Blue#1, gelatin, glycerin, polyethylene glycol-400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

1-800-632-6900

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

GLUTEN FREE

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of
UNISOM® SLEEPGELS®**

NDC 30142-228-32

NDC 30142-228-40

NDC 30142-228-64

Kroger®

Sleep-Aid Softgels
MAXIMUM STRENGTH

Diphenhydramine HCI 50 mg

Nighttime Sleep Aid
Safe, Non-Habit Forming

32/40/64
LIQUID FILLED SOFTGELS one softgel per dose

actual size

**Unisom® SleepGels® is a registered trademark
of Chattem, Inc., Chattanooga, TN 37409.
Chattem, Inc., is not affiliated with The Kroger Co.
or this product. image description

image descriptionimage description

MAXIMUM STRENGTH SLEEP AID 
diphenhydramine hcl capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-228
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
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (903) Size13mm
FlavorImprint Code 206
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-228-321 in 1 CARTON04/17/2019
132 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:30142-228-401 in 1 CARTON04/17/2019
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:30142-228-641 in 1 CARTON04/17/2019
364 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/17/2019
Labeler - KROGER COMPANY (006999528)

Revised: 11/2022
Document Id: ee27996e-ae0c-6fc5-e053-2a95a90a4953
Set id: 570b5fbb-bf0e-4276-b1e7-61d31985cc42
Version: 8
Effective Time: 20221123
 
KROGER COMPANY