CVS HEALTH NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

CVS Health Nighttime Sleep-Aid by

Drug Labeling and Warnings

CVS Health Nighttime Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• ▪ for the 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

• ▪ a breathing problem such as asthma, emphysema, or chronic bronchitis
• ▪ glaucoma
• ▪ difficulty in urination due to enlargement of the prostate gland
• ▪ heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep- aid.

When using this product

• ▪ avoid alcoholic beverages and other drugs that cause drowsiness
• ▪ drowsiness will occur
• ▪ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.1-800-222-1222

Directions

• ▪ take only one dose per day (24 hours) – see Overdose warning
• ▪ measure with dosing cup provided

• adults & children 12 yrs & over:

  One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

• Children under 12 yrs:

  Do not use

Other information

• ▪ each 30 mL dose (2 tablespoons) contains: sodium 23 mg
• ▪ store at room temperature
• ▪ protect from light. Does not meet USP <671>.

Inactive ingredients

anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL

CVS Health ™

Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

NDC: 59779-893-12

SEE NEW WARNINGS

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL

•   Non-habit forming
•   Not for treating cold or flu

Berry Flavor

Naturally & artificially flavored

12 FL OZ (354 mL)

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.

TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

*This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil™.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2017CVS/pharmacy

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INGREDIENTS AND APPEARANCE

CVS HEALTH NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-893
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-893-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	02/11/2015

Labeler - CVS Pharmacy,Inc. (062312574)