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PediaCare Single Dose Fever Reducer (Medtech Products Inc.)

Available Formats

Dosage Form Package Information Links
LIQUID 6 DOSE PACK in 1 BOX, UNIT-DOSE (63029-010-10) > 10 mL in 1 DOSE PACK Label Information

Complete PediaCare Single Dose Fever Reducer Information

  • SPL UNCLASSIFIED SECTION

    CHILDREN
    Ages 6-8 NEW!
    or 48-59 lbs

    Drug Facts


  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg


  • Purpose

    Fever reducer/pain reliever


  • Uses:

    temporarily

    • reduces fever
    • relieves minor aches and pains due to:
            â—‹ the common cold
            â—‹ flu
            â—‹ headache
            â—‹ sore throat
            â—‹ toothache

  • 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 not sure 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

          Each packet provides 1 dose for a child who is 48 to 59 pounds or 6 to 8 years of age. If possible, use weight to determine dose; otherwise use age.

    To use:

          Fold back at the dotted line to reveal the tear strip.

          Tear across (not up & down) at the exposed tear slit

          Remove and discard strip

          Squeeze medicine into child’s mouth.

          If needed, repeat dose every 4 hours while symptoms last.

          Do not give more than 5 times in 24 hours (see overdose warning).

          Do not give more than 5 days unless directed by a doctor.


  • Other information

          Store at room temperature

          See bottom panel for lot number and expiration date

          Keep this box for future reference


  • Inactive ingredients

    citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum


  • Questions or comments?

    1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com


  • PRINCIPAL DISPLAY PANEL

    Children Ages 6-8
    or 48-59 lbs
    PediaCare Squeezable Packet
    Fever Reducer
    Pain Reliever
    Acetaminophen
    160mg/5mL
    Oral Suspension
    6 Single Dose Packets
    0.34 FL OZ (10 mL) EACH

    Children Ages 6-8
or 48-59 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen 
160mg/5mL
Oral Suspension
6 Single Dose Packets
0.34 FL OZ (10 mL) EACH

    CHILDREN
    Ages 4-5 NEW!
    or 36-47 lbs

    Drug Facts


  • Active ingredient

    (in each 5 mL)

    Acetaminophen 160 mg


  • Purpose

    Fever reducer/pain reliever


  • Uses:

    temporarily

    • reduces fever
    • relieves minor aches and pains due to:
            â—‹ the common cold
            â—‹ flu
            â—‹ headache
            â—‹ sore throat
            â—‹ toothache

  • 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 not sure 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

          Each packet provides 1 dose for a child who is 36 to 47 pounds or 4 to 5 years of age. If possible, use weight to determine dose; otherwise use age.

    To use:

          Fold back at the dotted line to reveal the tear strip.

          Tear across (not up & down) at the exposed tear slit

          Remove and discard strip

          Squeeze medicine into child’s mouth.

          If needed, repeat dose every 4 hours while symptoms last.

          Do not give more than 5 times in 24 hours (see overdose warning).

          Do not give more than 5 days unless directed by a doctor.


  • Other information

          Store at room temperature

          See bottom panel for lot number and expiration date

          Keep this box for future reference


  • Inactive ingredients

    citric acid, FD&C red no.40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose/carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol, sucralose, xanthan gum


  • Questions or comments?

    1-888-474-3099 Mon.-Fri. 8 am to 8 pm EST PediaCare.com


  • PRINCIPAL DISPLAY PANEL

    Children Ages 4-5
    or 36-47 lbs
    PediaCare Squeezable Packet
    Fever Reducer
    Pain Reliever
    Acetaminophen
    160mg/5mL
    Oral Suspension
    7 Single Dose Packets
    0.25 FL OZ (7.5 mL) EACH

    Children Ages 4-5
or 36-47 lbs
PediaCare Squeezable Packet
Fever Reducer
Pain Reliever
Acetaminophen 
160mg/5mL
Oral Suspension
7 Single Dose Packets
0.25 FL OZ (7.5 mL) EACH


  • INGREDIENTS AND APPEARANCE
    PEDIACARE SINGLE DOSE FEVER REDUCER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-075
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-075-07 7 in 1 BOX, UNIT-DOSE
    1 7.5 mL in 1 DOSE PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/15/2013
    PEDIACARE SINGLE DOSE FEVER REDUCER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-010-10 6 in 1 BOX, UNIT-DOSE
    1 10 mL in 1 DOSE PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 05/15/2013
    Labeler - Medtech Products Inc. (122715688)