Panadol Suspension
FDA Label NDC 0135-0539

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 0135-0539). 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 5 ml), purposes, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, 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 5 Ml)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • colds
    • flu
    • headache
    • toothache
    • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

    • 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 Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 5 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.

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 even if you do not notice any signs or symptoms.

Directions:

this product does not contain directions or complete warnings for adult use

  • do not take more than directed (see overdose warning)
  • find right dose in chart. If possible use weight to dose; otherwise, use age
  • if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor
  • do not take more than 5 doses in 24 hours, unless directed by a doctor
  • use only with enclosed pre-marked measuring syringe for accuracy. Do not use any other dosing device.

    • Age

    Weight

    Dosage

    under 2 yrs

    under 24 lbs

    ask a doctor

    2-3 yrs

    24-35 lbs

    5 mL

Other Information

  • store below 30°C (86°F)

Inactive Ingredients

benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution *contains one or more of these ingredients

Questions Or Comments?

1-800-455-7139 (English/Spanish) weekdays

Keep Carton

Principal Display Panel

NDC 0135-0539-02

Panadol®

Infants’

ACETAMINOPHEN

160 mg per 5 mL

LIQUID

Pain Reliever

Fever Reducer

SEE NEW WARNINGS INFORMATION

Ages 2-3 years

Fast relief of fever and pain

Gentle on your stomach

  • Ibuprofen free
  • No sugar added
  • Aspirin free

    • artificial

    raspberry flavor

    Dosing Device Inside

    l.85 fl oz (54.7 mL)

    Tamper Evident Feature: Do not use if printed overwrap is missing or broken.

    READ AND KEEP CARTON FOR COMPLETE INFORMATION

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

    Made in Canada

    ©2015 GSK

    All Rights Reserved.

    USING THE CONVENIENT DOSING DEVICE

    • Shake the bottle well. Push the dosing device firmly into the bottle’s neck.
    • Turn the bottle upside down. Holding the device in place, gently pull the plunger out to draw the correct dose.
    • With the bottle in an upright position, remove the device from the plug and bottle by gently pulling it. Place the end of the device into the child’s mouth. Administer dose by pressing the plunger slowly.

      • After use, replace the cap. Wash the device in warm water and allow to dry.

      PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.

      Keep Carton

      102012XB (A134044)

* Please review the disclaimer below.