NIGHTTIME SLEEP AID- diphenhydramine hcl tablet 
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 caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

provides relief of occasional sleeplessness

Warnings

Do not use

  • with any other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Do not take more than directed

  • adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other information

  • each caplet contains: calcium 25 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake,
magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of TYLENOL® SIMPLY SLEEP®  **See bottom panel

Nighttime Sleep-Aid

Diphenhydramine HCl, 25 mg

Does NOT Contain Pain Reliever

Fall Asleep Fast

Wake up Rested

NON-HABIT FORMING

MINI-CAPLETS***   (***capsule-shaped tablets)

**Tylenol® Simply Sleep® is a registered trademark of McNeil Consumer Healthcare, Fort Washington, PA 19034. McNeil Consumer Healthcare is not affiliated with The Kroger Co. or this product. 

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

GLUTEN FREE

Product Label

Diphenhydramine 25 mg

Kroger Nighttime Sleep Aid Mini Tablet

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code T129;S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-401-242 in 1 CARTON11/02/201212/31/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33611/02/201212/31/2019
Labeler - The Kroger Co. (006999528)

Revised: 12/2018
Document Id: 2e6664b4-0abd-41a4-8313-0e597f0baa72
Set id: 365ee0e0-a15c-4ae0-93ad-45379a6a24ba
Version: 3
Effective Time: 20181214
 
The Kroger Co.