PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]

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PANADOL (ACETAMINOPHEN) SUSPENSION [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]
PDF | XML
NDC 0135-0539-02
Set ID 95801755-db54-4ad7-bec1-52671914f6ca
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART343
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  • 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.

    Keep out of reach of children.

    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)

    Panadol Infants 1.85 fl oz carton
  • INGREDIENTS AND APPEARANCE
    PANADOL 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0539
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (light red) Score    
    ShapeSize
    FlavorRASPBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0539-021 in 1 CARTON10/15/2012
    154.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/15/2012
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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