NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled
CVS Pharmacy

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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CVS 44-656

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

for 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

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 over: 1 capsule (50 mg) at bedtime if needed, or as directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat
use by expiration date on package

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal Display Panel

CVS
Health™

Compare to the active ingredient
in Unisom® SleepGels®*

Softgels

NDC 59779-956-46

Nighttime
Sleep-Aid

DIPHENHYDRAMINE HCl 50 mg

Nighttime sleep-aid

• Fall asleep fast
• Easy to swallow

Actual Size

96 LIQUID-FILLED CAPSULES

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

*This product is not manufactured or distributed by Chattem,
Inc., owner of the registered trademark Unisom® SleepGels®.
50844 ORG031565646

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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CVS.com® 1-800-SHOP CVS
Product of China
Packaged and Quality
Assured in the U.S.A.
V-11112

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CVS 44-656

NIGHTTIME SLEEP AID
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-956
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	blue (clear)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	656
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-956-19	1 in 1 CARTON	03/01/2015	10/20/2019
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:59779-956-46	96 in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015	04/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	03/01/2015	04/19/2020

Labeler - CVS Pharmacy (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(59779-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(59779-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(59779-956)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(59779-956)

Revised: 7/2021

Document Id: 9d860954-0c86-4426-a7da-1edbae4fb63f

Set id: 912194a6-4d9b-4a88-8a5a-84965cd387d6

Version: 9

Effective Time: 20210706

CVS Pharmacy