Cvs Health Nighttime Sleep-Aid (Diphenhydramine Hydrochloride) Liquid [Cvs Pharmacy,inc.] -

CVS HEALTH NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]
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NDC	59779-893-06
Set ID	a575a914-14a0-442c-a504-ac7a0aa0ac77
Category	HUMAN OTC DRUG LABEL
Packager	CVS Pharmacy,Inc.
Generic Name
Product Class
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient (in each 30 mL)

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 at 1-800-222-1222.
Directions

▪

take only one dose per day (24 hours) – see Overdose warning

▪

measure with dosing cup provided

adults & children 12yrs & 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 contains: potassium 5 mg; sodium 10 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™

NDC 59779-893-06

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

Alcohol Free
Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCl

Non-habit forming

Not for treating cold or flu

Berry Flavor

Naturally and Artificially Flavored

6 FL OZ (177 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 Procter & Gamble, the distributor of ZzzQuil®

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-893-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/22/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/22/2015

Labeler - CVS Pharmacy,Inc. (062312574)

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Medic

CVS HEALTH NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CVS PHARMACY,INC.]

Do not use

Ask a doctor before use if you have

When using this product

Overdose warning:

Related Drugs

adults & children 12yrs & 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