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)

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

Ask a doctor before use if you have

• a breathing problem such as emphysema, or chronic bronchitis
• glaucoma
• 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 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.

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)
• Measure with dosing cup provided

• adults & children 12 yrs & over:
  • One Dose = 30 mL 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 requirements for light-resistant packaging

Inactive ingredients

anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

CVS Health™

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

NDC 69842-753-12

Alcohol Free

Nighttime

Sleep-Aid

Diphenhydramine HCl, 50 mg

Non – habit forming

DYE FREE

BERRY FLAVOR

12 FL OZ (354 mL)

SEE NEW WARNINGS.

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™ Nighttime Sleep-Aid.

DISTRIBUTED BY: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2018 CVS/ Pharmacy

CVS .com® 1-800-SHOP CVS

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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: 69842-753
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)
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		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-753-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/11/2017

Labeler - CVS Pharmacy,Inc. (062312574)