KROGER NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet

Drug Facts
Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg
Purpose

Nighttime sleep-aid
Use

for the relief of occasional sleeplessness
WARNINGS

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 DOCTOR/PHARMACIST

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.
PREGNANCY OR BREAST FEEDING

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

Drug Facts (continued)
KEEP OUT OF REACH OF CHILDREN

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

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.

INGREDIENTS AND APPEARANCE

KROGER NIGHTTIME SLEEP AID
diphenhydramine hydrochloride tablet

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 30142-116-01	1 in 1 CARTON	04/16/2019
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	04/16/2019

Labeler - KROGER COMPANY (006999528)

Registrant - Spirit Pharmaceuticals LLC (179621011)

Name	Address	ID/FEI	Business Operations
Establishment
MEDGEL PRIVATE LIMITED		677385498	manufacture(30142-116)

Kroger NIGHTTIME SLEEP AID by