Vicks ®

Vicks ®
SPL v5
SPL
SPL Set ID 0ad7b313-5d72-4cc0-97f0-1a30770350af
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

Uses

for the temporary relief of minor aches and pains associated with:

  • sore throat
  • headache
  • muscular aches
  • backache
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.

Section 50566-9

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.

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • a sodium-restricted diet
Section 50570-1

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.
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 as directed
  • do not exceed 3 doses (30 mL each) per day (24 hours)
  • only use the dose cup provided
adults & children 12 yrs & over 30 mL every 6 hours
children under 12 yrs ask a doctor

Questions?

1-877-881-5813

Other Information
  • each 30 mL contains: sodium 93 mg
  • do not exceed 25°C and do not refrigerate.
Inactive Ingredients

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredients (in Each 30 Ml)

Acetaminophen 1000 mg

Principal Display Panel 354 Ml Bottle

VICKS ®

PainQuil

PAIN RELIEVER

Acetaminophen

STARTS WORKING FAST

FOR RELIEF OF:

ACHES | PAINS

HEADACHE | SORE THROAT

BLACK CHERRY FLAVORED

Alcohol 10%

12 FL OZ (354 ml)


Structured Label Content

Uses

for the temporary relief of minor aches and pains associated with:

  • sore throat
  • headache
  • muscular aches
  • backache
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.

Section 50566-9 (50566-9)

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.

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • a sodium-restricted diet
Section 50570-1 (50570-1)

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.
Purpose

Pain reliever

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 as directed
  • do not exceed 3 doses (30 mL each) per day (24 hours)
  • only use the dose cup provided
adults & children 12 yrs & over 30 mL every 6 hours
children under 12 yrs ask a doctor

Questions? (QUESTIONS?)

1-877-881-5813

Other Information (Other information)
  • each 30 mL contains: sodium 93 mg
  • do not exceed 25°C and do not refrigerate.
Inactive Ingredients (Inactive ingredients)

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

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

Principal Display Panel 354 Ml Bottle (PRINCIPAL DISPLAY PANEL - 354 ml bottle)

VICKS ®

PainQuil

PAIN RELIEVER

Acetaminophen

STARTS WORKING FAST

FOR RELIEF OF:

ACHES | PAINS

HEADACHE | SORE THROAT

BLACK CHERRY FLAVORED

Alcohol 10%

12 FL OZ (354 ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)