1. Home
  2. Labeler Index
  3. Haleon Us Holdings Llc
  4. 0135-0539
  5. Label Information: Panadol

FDA Label for Panadol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    8. STOP USE AND ASK A DOCTOR IF
    9. OVERDOSE WARNING:
    10. DIRECTIONS:
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Panadol Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.