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 44-727

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

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 right away.

Directions

do not take more than directed
take only one dose per day (24 hours)
adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
protect from light, heat and moisture
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

1-800-426-9391

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♥CVS
Health®

Compare to the active ingredient in Vicks® ZzzQuil® NIGHTTIME SLEEP-AID LiquiCaps®*

Nighttime
Sleep-Aid

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid
Non-habit forming

Not for treating pain,
cold or flu

Actual Size

24 LIQUID-FILLED CAPSULES

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

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME
SLEEP-AID LiquiCaps®.

50844 ORG012072708

Product of Dubai
Packaged & quality assured in the U.S.A.
V-11112

CVS® Quality
Money Back Guarantee

CVS Health 44-727

SLEEP-AID
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-774
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	purple	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	727
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-774-08	2 in 1 CARTON	12/25/2020	12/03/2023
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:69842-774-22	4 in 1 CARTON	12/25/2020	12/03/2023
2		12 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	part338	12/25/2020	12/03/2023

Labeler - CVS PHARMACY (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(69842-774)

Revised: 7/2022

Document Id: 4369f711-d9bd-4e74-a287-9bb42dada01b

Set id: c1a0c792-a7e7-47ef-a076-9345a279125a

Version: 5

Effective Time: 20220713

CVS PHARMACY