Vicks ®

Vicks ®
SPL v1
SPL
SPL Set ID 32bedbbc-b939-1bea-e063-6394a90a6934
Route
ORAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg) Acetaminophen (1000 mg)
Inactive Ingredients
Propylene Glycol Alcohol Polysorbate 20 Anhydrous Citric Acid Water Saccharin Sodium Trisodium Citrate Dihydrate Fd&c Red No. 40 Fd&c Green No. 3 D&c Yellow No. 10 Fd&c Yellow No. 6 Glycerin Sodium Benzoate Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-06

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 50569-3

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
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 dose contains: sodium 21 mg
  • store at no greater than 25°C (77ºF) and do not refrigerate.
Inactive Ingredients

alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water

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.

Keep Out of Reach of Children.

If Pregnant Or Breast Feeding, 

ask a health professional before use.

Active Ingredients (in Each 30 Ml)

Acetaminophen 1000 mg

Diphenhydramine HCl 50 mg

Principal Display Panel 354 Ml Bottle

VICKS ®

PainQuilPM

PAIN RELIEVER + NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

STARTS WORKING FAST

FOR RELIEF OF:

ACHES | PAINS

HEADACHE | SORE THROAT

+ OCCASSIONAL SLEEPLESSNESS

HONEY FLAVORED

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 50569-3 (50569-3)

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
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 dose contains: sodium 21 mg
  • store at no greater than 25°C (77ºF) and do not refrigerate.
Inactive Ingredients (Inactive ingredients)

alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

VICKS ®

PainQuilPM

PAIN RELIEVER + NIGHTTIME SLEEP-AID

Acetaminophen

Diphenhydramine HCl

STARTS WORKING FAST

FOR RELIEF OF:

ACHES | PAINS

HEADACHE | SORE THROAT

+ OCCASSIONAL SLEEPLESSNESS

HONEY FLAVORED

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

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