Label: PANADOL- acetaminophen suspension

  • NDC Code(s): 0135-0537-01, 0135-0537-02, 0135-0537-03
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/14

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5mL)

    Acetaminophen 160 mg

    Close
  • Purposes

    Pain reliever/fever reducer

    Close
  • Uses

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

    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.

    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.

    Close
  • 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 cup 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*

    4 – 5 yrs

    36 – 47 lbs

    7.5 mL

    6 – 8 yrs

    48 – 59 lbs

    10 mL

    9 – 10 yrs

    60 – 71 lbs

    12.5 mL

    11 yrs

    72 – 95 lbs

    15 mL

    *mL=milliliter

    Close
  • Other information

    store below 30°C (86°F)
    Close
  • 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

    Close
  • Questions or comments?

    1-800-981-3511 (English/Spanish) weekdays

    Close
  • Principal Display Panel

    NDC 0135-0537-03

    Panadol®

    Children’s

    ACETAMINOPHEN

    LIQUID

    Pain Reliever

    Fever Reducer

    Ages 2-11 years

    Fast relief of fever and pain

    Gentle on your stomach

    Ibuprofen free
    No sugar added
    Aspirin free

    artificial

    raspberry flavor

    4 fl oz (118 mL)

    160 mg in each 5 mL

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

    Read and keep carton for complete information

    PANADOL is a registered trademark of the GlaxoSmithKline group of companies.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108 U.S.A.

    Made in Canada

    ©2012 GlaxoSmithKline

    Keep Carton

    102003XA (A103640)

    Panadol Childrens liquid 4 fl oz carton
    Close
  • INGREDIENTS AND APPEARANCE
    PANADOL 
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0537
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    FD&C RED NO. 40  
    GLYCERIN  
    HYDROCHLORIC ACID  
    POLYETHYLENE GLYCOLS  
    POTASSIUM SORBATE  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM HYDROXIDE  
    SACCHARIN SODIUM  
    SORBITOL  
    Product Characteristics
    Color RED (light red) Score     
    Shape Size
    Flavor RASPBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0537-01 1 in 1 CARTON 10/15/2012
    1 15 mL in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:0135-0537-02 1 in 1 CARTON 10/15/2012
    2 54.7 mL in 1 BOTTLE; Combination Product Type = C112160
    3 NDC:0135-0537-03 1 in 1 CARTON 10/15/2012
    3 118 mL in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 10/15/2012
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
    Close