KROGER NIGHTTIME SLEEP AID CAPLET- diphenhydramine hydrochloride tablet, film coated 
The Kroger Co.

----------

Nighttime Sleep Aid CAPLET

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

for relief of occasional sleeplessness

Warnings

Do not use
• in 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
• drowsiness will occur
• 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 serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 

Directions

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

Other information

each caplet contains: calcium 19 mg
• store at room temperature between 20°-25°C (68°-77°F). Avoid high humidity. Protect from light.

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

call 1-800-632-6900

Compare to the active ingredient of TYLENOL® PM Simply Sleep®*

Does Not Contain Pain Reliever

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

Product of India

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® PM Simply Sleep®.

Packaging

KROGER-601

KROGER NIGHTTIME SLEEP AID CAPLET 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-601
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (Oblong) Size11mm
FlavorImprint Code DB
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59450-601-011 in 1 CARTON02/01/2024
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01002/01/2024
Labeler - The Kroger Co. (006999528)

Revised: 1/2024
Document Id: c548ef0a-5d1f-4b35-b29a-12abf4663212
Set id: f0f3f58d-9457-4697-98e6-ef52d350cf67
Version: 1
Effective Time: 20240129
 
The Kroger Co.