Vicks ZzzQuil Night Pain Liquid

Vicks ZzzQuil by

Drug Labeling and Warnings

Vicks 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]

VICKS ZZZQUIL NIGHT PAIN- diphenhydramine hydrochloride and acetaminophen liquid 
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 Night Pain Liquid

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Purpose

Pain reliever

Nighttime sleep-aid

Use

• for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product

taken with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include: skin reddening blisters rash

If a skin reaction occurs, stop use and seek medical help right away

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• avoid alcoholic beverages
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

These could be signs of a serious condition.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

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

• adults & children 12 yrs & over: 30 mL at bedtime
• children under 12 yrs: do not use

Other information

• each 30 mL contains: sodium 151 mg
• store at no greater than 25°C and do not refrigerate

Inactive ingredients

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavors, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum.

Questions?

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 - 354 ml bottle

VICKS ®

ZzzQuil™
NIGHT PAIN
NIGHTTIME SLEEP-AID

PAIN RELIEVER

Diphenhydramine HCl

Acetaminophen

Fall Asleep Fast

Max Strength Pain Reliever

Non-Habit Forming

Midnight Berry

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

VICKS ZZZQUIL  NIGHT PAIN
diphenhydramine hydrochloride and acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-975
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	1000 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-975-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M010	06/01/2020	06/01/2020

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 9/2023

Document Id: 065d78e6-3d65-4047-e063-6294a90aa87f

34390-5

Set id: a7d100bf-46ad-4279-e053-2a95a90a3506

Version: 10

Effective Time: 20230927

 

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