Nighttime Sleep Aid by The Kroger Co. Drug Facts

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by The Kroger Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Kroger Nighttime Sleep Aid Mini Tablet

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T129;S25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-401-24	2 in 1 CARTON	11/02/2012	12/31/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	11/02/2012	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: 2e6664b4-0abd-41a4-8313-0e597f0baa72

34390-5

Set id: 365ee0e0-a15c-4ae0-93ad-45379a6a24ba

Version: 3

Effective Time: 20181214