Label: PEDIACARE INFANT FEVER PAIN RELIEVER- acetaminophen liquid

  • NDC Code(s): 63029-700-01, 63029-722-01, 63029-733-01
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11/11

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts – Cherry Flavor

    Close
  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg

    Close
  • Purpose

    Fever reducer/pain reliever

    Close
  • Uses:

    temporarily reduces fever; temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is 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.

    When using this product

    • do not exceed recommended dosage (see overdose warning)

    Stop use and ask a doctor if:

    • pain gets worse or lasts for more than 5 days.
    • fever gets worse or lasts for more than 3 days.
    • new symptoms occur.
    • redness or swelling is present.

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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.
    • Shake well before using.
    • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    • Remove cap and insert syringe into hole at top of bottle and turn upside down.
    • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
    • If needed, repeat dose every 4 hours while symptoms last.
    • Do not use more than 5 times in 24 hours (see overdose warning).
    • Replace cap tightly to maintain child resistance.
    • mL = milliliter, tsp = teaspoon
    Weight (lb) Age (yr) Dose (mL)
    under 24 under 2 Ask a doctor
    24-35 2-3 5 mL
    Close
  • Other information

    • store at room temperature
    • each teaspoon contains: sodium 2 mg
    • see bottom panel for lot number and expiration date
    Close
  • Inactive ingredients

    acesulfame potassium, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 40, sodium benzoate, sorbitol, xanthan gum

    Close
  • Questions or comments?

    Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







    Drug Facts – Bubble Gum Flavor

    Close
  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg

    Close
  • Purpose

    Fever reducer/pain reliever

    Close
  • Uses:

    temporarily reduces fever; temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is 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.

    When using this product

    • do not exceed recommended dosage (see overdose warning)

    Stop use and ask a doctor if:

    • pain gets worse or lasts for more than 5 days.
    • fever gets worse or lasts for more than 3 days.
    • new symptoms occur.
    • redness or swelling is present.

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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.
    • Shake well before using.
    • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    • Remove cap and insert syringe into hole at top of bottle and turn upside down.
    • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
    • If needed, repeat dose every 4 hours while symptoms last.
    • Do not use more than 5 times in 24 hours (see overdose warning).
    • Replace cap tightly to maintain child resistance.
    • mL = milliliter, tsp = teaspoon
    Weight (lb) Age (yr) Dose (mL)
    under 24 under 2 Ask a doctor
    24-35 2-3 5 mL
    Close
  • Other information

    • store at room temperature
    • each teaspoon contains: sodium 2 mg
    • see bottom panel for lot number and expiration date
    Close
  • Inactive ingredients

    butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 33, red 40, sodium benzoate, sorbitol, sucralose, xanthan gum

    Close
  • Questions or comments?

    Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







    Drug Facts – Grape Flavor

    Close
  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg

    Close
  • Purpose

    Fever reducer/pain reliever

    Close
  • Uses:

    temporarily reduces fever; temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
    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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or non-prescription). If you are unsure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is 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.

    When using this product

    • do not exceed recommended dosage (see overdose warning)

    Stop use and ask a doctor if:

    • pain gets worse or lasts for more than 5 days.
    • fever gets worse or lasts for more than 3 days.
    • new symptoms occur.
    • redness or swelling is present.

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 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.
    • Shake well before using.
    • Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • Only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
    • Remove cap and insert syringe into hole at top of bottle and turn upside down.
    • Pull back syringe until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
    • If needed, repeat dose every 4 hours while symptoms last.
    • Do not use more than 5 times in 24 hours (see overdose warning).
    • Replace cap tightly to maintain child resistance.
    • mL = milliliter, tsp = teaspoon
    Weight (lb) Age (yr) Dose (mL)
    under 24 under 2 Ask a doctor
    24-35 2-3 5 mL
    Close
  • Other information

    • store at room temperature
    • each teaspoon contains: sodium 2 mg
    • see bottom panel for lot number and expiration date
    Close
  • Inactive ingredients

    blue 1, butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, red 33, sodium benzoate, sorbitol, sucralose, xanthan gum

    Close
  • Questions or comments?

    Call 1-888-474-3099 Mon. – Fri. 8:00 am to 8:00 pm EST or visit us at www.PediaCare.com.







    Close
  • PRINCIPAL DISPLAY PANEL

    NEW Accurate Dosing
    INFANTS 0-36 months
    PediaCare® we care for kidsTM
    Fever Reducer Pain Reliever
    ACETAMINOPHEN Oral Suspension
    Cherry Flavor
    2 FL OZ (59 mL)

    PRINCIPAL DISPLAY PANEL
NEW Accurate Dosing
INFANTS 0-36 months
PediaCare we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Cherry Flavor
2 FL OZ (59 mL)

    Close
  • PRINCIPAL DISPLAY PANEL

    NEW Accurate Dosing
    INFANTS 0-36 months
    PediaCare® we care for kidsTM
    Fever Reducer Pain Reliever
    ACETAMINOPHEN Oral Suspension
    Bubble Gum Flavor
    2 FL OZ (59 mL)

    PRINCIPAL DISPLAY PANEL
NEW Accurate Dosing
INFANTS 0-36 months
PediaCare we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Bubble Gum Flavor
2 FL OZ (59 mL)

    Close
  • PRINCIPAL DISPLAY PANEL

    NEW Accurate Dosing
    INFANTS 0-36 months
    PediaCare® we care for kidsTM
    Fever Reducer Pain Reliever
    ACETAMINOPHEN Oral Suspension
    Grape Flavor
    2 FL OZ (59 mL)

    PRINCIPAL DISPLAY PANEL
NEW Accurate Dosing
INFANTS 0-36 months
PediaCare we care for kidsTM
Fever Reducer Pain Reliever
ACETAMINOPHEN Oral Suspension
Grape Flavor
2 FL OZ (59 mL)

    Close
  • INGREDIENTS AND APPEARANCE
    PEDIACARE INFANT FEVER PAIN RELIEVER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63029-700
    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
    ACESULFAME POTASSIUM  
    BUTYLPARABEN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    POWDERED CELLULOSE  
    CITRIC ACID  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    PROPYLENE GLYCOL  
    WATER  
    FD&C RED NO. 40  
    SODIUM BENZOATE  
    SORBITOL  
    XANTHAN GUM  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-700-01 1 in 1 CARTON
    1 59 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 10/15/2011
    PEDIACARE INFANT FEVER PAIN RELIEVER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63029-733
    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
    BUTYLPARABEN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    POWDERED CELLULOSE  
    CITRIC ACID  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    PROPYLENE GLYCOL  
    WATER  
    FD&C RED NO. 40  
    SODIUM BENZOATE  
    SORBITOL  
    XANTHAN GUM  
    D&C RED NO. 33  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-733-01 1 in 1 CARTON
    1 59 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 10/15/2011
    PEDIACARE INFANT FEVER PAIN RELIEVER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63029-722
    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
    BUTYLPARABEN  
    CARBOXYMETHYLCELLULOSE SODIUM  
    POWDERED CELLULOSE  
    CITRIC ACID  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    XANTHAN GUM  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-722-01 1 in 1 CARTON
    1 59 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 10/15/2011
    Labeler - Medtech Products Inc. (122715688)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries Inc 113044205 MANUFACTURE
    Close