DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

DIPHENHYDRAMINE HYDROCHLORIDE by

Drug Labeling and Warnings

DIPHENHYDRAMINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

■ glaucoma

■ a breathing problem such as emphysema or chronic bronchitis

■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

■ use caution when driving a motor vehicle or operating machinery ■ drowsiness will occur

■ avoid alcoholic beverages

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.

Directions

■ do not take more than directed

■ 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 37 mg

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ protect from moisture

■ use by expiration date on package

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark

Simply Sleep®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2018 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-34571

PRINCIPAL DISPLAY PANEL

CVSHealth

Compare to the active ingredient in Simply Sleep®*

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Safe, non-habit forming

Fall asleep fast, wake up rested

Does not contain pain reliever

365 MINI-CAPLETS

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-834
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	CPC;2824
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-834-51	365 in 1 BOTTLE; Type 0: Not a Combination Product	07/23/2018
2	NDC: 69842-834-55	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	07/23/2018

Labeler - CVS Pharmacy, Inc. (062312574)