Vicks ®

Vicks ®
SPL v1
SPL
SPL Set ID 47683352-c3c7-13cd-e063-6294a90af6bf
Route
ORAL
Published
Effective Date 2026-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg) Acetaminophen (1000 mg)
Inactive Ingredients
Alcohol Propylene Glycol Fd&c Blue No. 1 D&c Yellow No. 10 Anhydrous Citric Acid Polysorbate 20 Saccharin Sodium Trisodium Citrate Dihydrate Water Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-03

Description

Drug Facts

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Drug Facts

Use
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 34088-5

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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Warnings

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

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

• 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

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

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
Questions?

1-877-881-5813

Other Information
  • each 30 mL dose cup contains: sodium 88 mg
  • store at no greater than 25°C and do not refrigerate
Inactive Ingredients

alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

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.

Active Ingredients (in Each 30 Ml)

Acetaminophen1000 mg

Diphenhydramine HCl 50 mg

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
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

Chill Mint Flavored

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Use
  • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Section 34088-5 (34088-5)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

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

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

• 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

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

Do Not Use (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
Questions?

1-877-881-5813

Other Information (Other information)
  • each 30 mL dose cup contains: sodium 88 mg
  • store at no greater than 25°C and do not refrigerate
Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No. 1, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen1000 mg

Diphenhydramine HCl 50 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel 354 Ml Bottle (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

Chill Mint Flavored

Not for colds

Alcohol 10%

12 FL OZ (354 ml)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)