NIGHTTIME SLEEP-AID SOFTGEL- diphenhydramine hydrochloride capsule, liquid filled

Nighttime Sleep-Aid Softgel by

Drug Labeling and Warnings

Nighttime Sleep-Aid Softgel by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC, Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

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  with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have  glaucoma  heart diseases  a breathing problem such as emphysema, asthma, 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, tranquilizers, or any other sleep aid

When using this product avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery

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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

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

Other information

store at 20-25°C (68-77°F)

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?

1-888-577-8033 Monday-Friday 9am-4:30pm EST

SPL UNCLASSIFIED SECTION

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

Non-habit forming

Not for treating pain, cold or flu

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

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

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product of UAE

Packaged and Quality Assured in the USA

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Packaging

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID SOFTGEL 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-779
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (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	779
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-779-24	2 in 1 CARTON	07/23/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51316-779-48	4 in 1 CARTON	07/23/2021
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	07/23/2021

Labeler - CVS PHARMACY, INC (062312574)