Vicks ®

Vicks ®
SPL v8
SPL
SPL Set ID 163a1617-b7f1-4c80-e063-6394a90a74c3
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg) Diphenhydramine (50 mg)
Inactive Ingredients
Alcohol Propylene Glycol Polysorbate 20 Saccharin Sodium Anhydrous Citric Acid Water Trisodium Citrate Dihydrate Fd&c Red No. 40 Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: red Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-07
Description

Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID Drug Facts

Purpose

Pain reliever Nighttime sleep-aid

Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID Drug Facts

Uses
  • 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

Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

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

  • more than 3 doses (30 mL each) in 24 hours, 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
  • only use as directed
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 contains: sodium 89 mg
  • do not exceed 25°C and do not refrigerate.
Inactive Ingredients

alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, 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
  • redness or swelling is present
  • 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)

Acetaminophen 1000 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 Convenience Pack

Vicks ®PainQuil™ PAIN RELIEVER / Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

MAX STRENGTH‡

VALUE PACK

‡Maximum strength dose of active ingredients per dosing interval, only use as directed.

Vicks ®PainQuil™ PAIN RELIEVER

STARTS WORKING FAST FOR RELIEF OF:

ACHES

PAINS

HEADACHE

SORE THROAT

BLACK CHERRY FLAVORED

Alcohol 10%

Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

STARTS WORKING FAST FOR RELIEF OF:

ACHES

PAINS

HEADACHE

SORE THROAT

+

OCCASSIONAL SLEEPLESSNESS

MIDNIGHT CHERRY FLAVORED

Alcohol 10%

2 BOTTLES - 1 PAINQUIL/1 PAINQUIL PM 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)

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

Structured Label Content

Uses
  • 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)

Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain reliever

Nighttime sleep-aid

Warnings

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

  • more than 3 doses (30 mL each) in 24 hours, 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • take only one dose (30 mL) per day (24 hours)
  • only use the dose cup provided
  • only use as directed
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 contains: sodium 89 mg
  • do not exceed 25°C and do not refrigerate.
Inactive Ingredients (Inactive ingredients)

alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, 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
  • redness or swelling is present
  • 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))

Acetaminophen 1000 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 Convenience Pack (PRINCIPAL DISPLAY PANEL - Convenience Pack)

Vicks ®PainQuil™ PAIN RELIEVER / Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

MAX STRENGTH‡

VALUE PACK

‡Maximum strength dose of active ingredients per dosing interval, only use as directed.

Vicks ®PainQuil™ PAIN RELIEVER

STARTS WORKING FAST FOR RELIEF OF:

ACHES

PAINS

HEADACHE

SORE THROAT

BLACK CHERRY FLAVORED

Alcohol 10%

Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID

STARTS WORKING FAST FOR RELIEF OF:

ACHES

PAINS

HEADACHE

SORE THROAT

+

OCCASSIONAL SLEEPLESSNESS

MIDNIGHT CHERRY FLAVORED

Alcohol 10%

2 BOTTLES - 1 PAINQUIL/1 PAINQUIL PM 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:23.078474 · Updated: 2026-03-14T23:10:46.361818