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 Co. Nighttime Sleep-Aid 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
•: 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

•: avoid alcoholic drinks
•: drowsiness may 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 (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 15 mg
•: store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
•: do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Principal Display Panel

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

See bottom panel

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Does NOT Contain Pain Reliever

For a Restful Night’s Sleep

SAFE, NON-HABIT FORMING

24 MINI-CAPLETS

actual size

NIGHTTIME SLEEP AID
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-431
Route of Administration	ORAL

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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	L431
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:30142-431-62	12 in 1 CARTON	08/07/2001	01/31/2020
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:30142-431-78	1 in 1 CARTON	03/02/2007	12/31/2020
2		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	02/05/2001	12/31/2020

Labeler - Kroger Company (006999528)

Revised: 12/2020

Document Id: fb9236a8-7e6e-40fc-bfe8-097d05f8aad8

Set id: 7a8c18fa-6e0b-4ea9-9dcb-ce4359d1a316

Version: 6

Effective Time: 20201201

Kroger Company