Vicks ZzzQuil™ Nighttime Sleep-Aid Diphenhydramine HCl FREE OF

ZzzQuil by

Drug Labeling and Warnings

ZzzQuil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZZZQUIL FREE OF- diphenhydramine hydrochloride solution 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vicks ZzzQuil™
Nighttime Sleep-Aid
Diphenhydramine HCl
FREE OF

Drug Facts

Active ingredient (in each 30 mL dose cup)

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 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take only one dose (30 mL) per day (24 hours)
• only use dose cup provided

• adults & children 12 yrs & over: 30 mL at bedtime if needed ; or as directed by a doctor
• children under 12 yrs: do not use

Other information

• each 30 mL dose cup contains: sodium 88 mg
• store at no greater than 25°C

Inactive ingredients

citric acid, glycerin, natural flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, water

Questions or comments?

1-877-881-5813

Tamper Evident: Do not use if printed shrinkband seal around the neck is broken or missing.

DIST. BY: PROCTER & GAMBLE

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL

Vicks®

ZzzQuil™

Nighttime Sleep-Aid

Diphenhydramine HCl

Free Of

High Fructose Corn Syrup

Alcohol

Artificial Dyes & Flavors

Fall Asleep Fast

Non-habit Forming

12 FL OZ (354 mL)

ZZZQUIL  FREE OF
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-965
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
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-965-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/19/2021	04/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M010	04/19/2021	04/19/2021

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 8/2023

Document Id: 0321c480-e152-421d-e063-6294a90ad687

34390-5

Set id: d2a50e5a-170f-5530-e053-2a95a90a2f16

Version: 5

Effective Time: 20230817

 

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