DG HEALTH SLEEP AID- diphenhydramine hydrochloride tablet
Dolgencorp Inc

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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Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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

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.

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)

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?

1-888-309-9030

Principal Display Panel

Compare to active ingredient of Simply Sleep® Nighttime Sleep Aid

Nite Time

Sleep Aid

Diphenhydramine HCl 25 mg

For a Restful Night’s Sleep

Safe, Non-Habit Forming

Does Not Contain Pain Reliever

Sleep Aid Carton Image 1

Sleep Aid Carton Image 2

DG HEALTH SLEEP AID
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-431
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
CROSPOVIDONE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
STEARIC ACID
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description
1	NDC:55910-431-62	2 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	01/24/2010

Labeler - Dolgencorp Inc (068331990)

Revised: 05/2012

Document Id: 80ae5169-2fae-43e0-b7da-abeff869d908

Set id: 038c1b4e-43f5-4370-896b-97da1b0a89ca

Version: 2

Effective Time: 20120524

Dolgencorp Inc