KROGER NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet 
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 NIGHTTIME SLEEP AID

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 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 ■ 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.

Drug Facts (continued)

Keep out of reach of children.

Overdose warning

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

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 23.52 mg
■ store between 20-25°C (68-77°F). Avoid high
humidity. Protect from light.

Inactive ingredients

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

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of SIMPLY SLEEP ® NIGHTTIME SLEEP AID CAPLETS*

Kroger

NDC 30142-116-01

Nighttime Sleep-Aid

Diphenhydramine HCl, 25mg

Does NOT contain Pain Reliever

For a Restful

Night's Sleep

SAFE, NON-HABIT FORMING

100

MINI-CAPLETS

actual size

*Simply Sleep® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933-7001. Johnson & Johnson is not affiliated with The Kroger Co. or this product.

image description

KROGER NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-116
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code S5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-116-011 in 1 CARTON04/16/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33804/16/2019
Labeler - KROGER COMPANY (006999528)
Registrant - Spirit Pharmaceuticals LLC (179621011)

Revised: 11/2022
Document Id: ee27996e-ae0b-6fc5-e053-2a95a90a4953
Set id: 8b600379-bbec-417d-8924-973eaba3d7d3
Version: 5
Effective Time: 20221123
 
KROGER COMPANY