Panadol Tablet, Film Coated
FDA Label NDC 0135-7011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Panadol (NDC 0135-7011). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/Fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • muscular aches
    • minor arthritis pain
    • temporarily reduces fever

Warnings

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

  • more than 8 caplets in 24 hours, which is the maximum daily amount
  • 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.

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

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
  • any new symptoms appear

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Overdose Warning:

Taking more than the recommended dose can cause serious health problems. 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.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor
  • do not take more than 8 caplets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor

Other Information

  • store below 25°C (77°F)
  • close cap tightly after use

Inactive Ingredients

castor oil, hypromellose, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions?

1-800-455-7139

Principal Display Panel

NDC 0135-7011-03

PANADOL

EXTRA STRENGTH

500

ACETAMINOPHEN

Pain Reliever

Fever Reducer

50 CAPLETS

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2020 GSK group of companies or its licensor.

Trademarks are owned by or licensed to the GSK group of companies.

Tamper-Evident Feature: Do not use if printed inner safety seal under cap is broken or missing.

READ AND KEEP CARTON FOR COMPLETE INFORMATION

B-0630-764-15 Front Carton

B-0630-764-15_panadol Es 500 50 Ct (Image 01)

B-0630-764-15_panadol Es 500 50 Ct (Image 01)

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