Active ingredient

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Uses

relief of occasional sleeplessness

Warnings

Do not use

with any other products containing diphenhydramine, including one used on skin
in children under 12 years of age

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

marked drowsiness may occur
avoid alcoholic beverages
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

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

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

Adults and children 12 years and over	take 2 tablets at bedtime if needed or as directed by a doctor
Children under 12 years of age	do not use

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Package/Label Principal Display Panel

Diphenhydramine HCl 25mg

SLEEP TABS FOR NIGHTTIME USE
diphenhydramine hcl tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69168-247
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	AZ247
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69168-247-24	24 in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product	04/28/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/28/2015

Labeler - Allegiant Health (079501930)

Drug Facts