Vicks Painquil Pm Liquid
FDA Label NDC 69423-834

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Painquil Pm (NDC 69423-834). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

    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.

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
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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
    • liver disease
    • a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
    • taking the blood thinning drug warfarin

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.

    • 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.

When Using This Product

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

Otc - Pregnancy Or Breast Feeding

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdosage

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.

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.

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