Label: UP AND UP DYE FREE INFANTS PAIN AND FEVER ACETAMINOPHEN- acetaminophen liquid

  • NDC Code(s): 11673-590-10, 11673-590-16
  • Packager: Target Corporation
  • 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 01/14

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

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily:

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

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  • 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 your child has ever had an allergic reaction to this product or any of its ingredients

    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 dose (see overdose warning)

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  • 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
    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 right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    this product does not contain directions or complete warnings for adult use
    do not give more than directed (see overdose warning)
    shake well before using
    mL = milliliter
    find right dose on chart. If possible, use weight to dose; otherwise, use age.
    push air out of syringe. Firmly push syringe into bottle opening.
    turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle.
    pull syringe until it reaches and stays at the correct dose
    dispense liquid slowly into child’s mouth, toward inner cheek
    repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    replace cap tightly to maintain child resistance

    Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    *or as directed by a doctor

    Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

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  • Other information

    store at 20-25ºC (68-77ºF)
    do not use if printed neckband is broken or missing
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  • Inactive ingredients

    anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

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  • Questions? Call

    Call 1-800-910-6874

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  • Principal Display Panel

    Compare to active ingredient in Infants’ Tylenol® Oral Suspension

    dye free infants’ pain and fever acetaminophen

    suspension liquid

    fever reducer/pain reliever

    see side panel for more information

    alcohol free, aspirin free, ibuprofen free

    no high fructose corn syrup

    use only with enclosed syringe

    non-staining

    CHERRY FLAVOR

    2 FL OZ (59 mL)

    160 mg per 5 mL

    SEE NEW DOSAGE AND DIRECTIONS

    Up and Up Dye Free Infants' Pain and Fever Acetaminophen Image
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  • INGREDIENTS AND APPEARANCE
    UP AND UP DYE FREE INFANTS PAIN AND FEVER ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-590
    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
    ANHYDROUS CITRIC ACID  
    CALCIUM SULFATE  
    CARRAGEENAN  
    GLYCERIN  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SUCRALOSE  
    SODIUM PHOSPHATE, TRIBASIC  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-590-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    2 NDC:11673-590-16 1 in 1 CARTON
    2 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/02/2011
    Labeler - Target Corporation (006961700)
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