vicks ®

vicks ®
SPL v8
SPL
SPL Set ID 65803fcd-3f5b-4c9d-85a1-2bf03ed6f68d
Route
oral
Published
Effective Date 2025-12-01
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 citric acid monohydrate polysorbate 20 saccharin sodium water fd&c red no. 40 sodium benzoate sodium chloride sodium citrate sorbitol sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2024-05-07

Purpose

Pain reliever Nighttime sleep-aid

Description

Drug Facts


Medication Information

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.

Purpose

Pain reliever

Nighttime sleep-aid

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

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

Description

Drug Facts

Questions?

1-877-881-5813

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.

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
  • 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.

Section 50567-7

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
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
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.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9

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

MIDNIGHT CHERRY FLAVORED

Alcohol 10%

12 FL OZ (354 ml)


Structured Label Content

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.

Purpose

Pain reliever

Nighttime sleep-aid

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

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

Questions?

1-877-881-5813

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.

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
  • 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.

Section 50567-7 (50567-7)

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
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
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.
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Section 53414-9 (53414-9)

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

MIDNIGHT CHERRY FLAVORED

Alcohol 10%

12 FL OZ (354 ml)


Advanced Ingredient Data


Raw Label Data

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