NIGHTTIME SLEEP-AID- diphenhydramine hcl tablet
WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

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.

----------

CVS 44-618 Delisted

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime Sleep-Aid

Uses

relieves occasional sleeplessness

Warnings

Do not use

in children under 12 years
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 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

adults and children 12 years and older: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
children under 12 years: do not use

Other information

each caplet contains: calcium 70 mg
avoid excessive heat (greater than 100ºF) or humidity
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn starch, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica gel

Questions or comments?

1-800-426-9391

Principal display panel

CVS
pharmacy™

NDC 59779-618-11
Compare to the active ingredient in Nytol® QuickCaps®*

NIGHTTIME
SLEEP AID
DIPHENHYDRAMINE HCl 25 mg
• Proven safe & effective
• Helps you fall asleep fast

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Nytol® QuickCaps®.
50844 ORG021361811

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
www.cvs.com
1-800-shop-CVS

V-11112

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

CVS 44-618

NIGHTTIME SLEEP-AID
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-618
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)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;618
Contains

#	Item Code	Package Description
Packaging
1	NDC:59779-618-11	6 in 1 CARTON
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/07/2013	02/26/2017

Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(59779-618)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(59779-618)

Revised: 10/2015

Document Id: cbdb2ba3-a3c1-4b18-a19b-9bfb19f249c4

Set id: 3434cf65-5e62-4e3e-8747-903f53096662

Version: 3

Effective Time: 20151013

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED