CVS HEALTH NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

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.1-800-222-1222

Directions

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 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
VALUE TWIN PACK

CVS Health™

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

NDC: 59779-893-24

SEE NEW WARNINGS

Alcohol Free

Nighttime

Sleep-Aid

DIPHENHYDRAMINE HCL
- Non-habit forming
- Not for treating cold or flu
Berry Flavor

Naturally & artificially flavored

2 BOTTLES

12 FL OZ (354 mL) EACH;

24 FL OZ (708 mL) TOTAL

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™ Nighttime Sleep- Aid.

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

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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 59779-893-24	2 in 1 PACKAGE, COMBINATION	07/14/2016
1		354 mL in 1 BOTTLE; 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	07/14/2016

Labeler - CVS Pharmacy,Inc. (062312574)

CVS Health Nighttime Sleep-Aid by