Label: EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY- acetaminophen liquid 

  • Label RSS
  • 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 11/09

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

  • Active Ingredients

    Acetaminophen 500 mg

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  • Purpose

    Acetaminophen....................Pain reliever/Fever reducer

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  • Uses

    • temporarily relieves minor aches and
    pains due to: • headache • muscular aches
    • backache • minor pain of arthritis
    • the common cold • toothache
    • premenstrual and menstrual cramps
    • temporarily reduces fever

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  • Warnings

    Liver warning: This product contains
    acetaminophen. Severe liver damage may
    occur if you take: • more than 4 doses
    (8 tablespoonfuls or 120 mL) in 24 hours,
    which is the maximum daily amount • with
    other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while
    using this product

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  • 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

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  • Ask a doctor before use if you have

    liver disease

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  • Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

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  • Stop use and ask a doctor if

    • pain gets worse or lasts for more than 10 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.

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  • If pregnant or breast-feeding

    ask a health professional before use.

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  • Keep this and all drugs out of the reach of children.

    Overdose warning: Taking more than the
    recommended dose (overdose) may cause liver
    damage. In case of accidental overdose, seek
    professional assistance or contact a Poison
    Control Center immediately. Quick medical
    attention is critical for adults as well as for
    children even if you do not notice any signs or
    symptoms.

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  • Directions

    • do not take more than directed
    (see overdose warning)
    • use only enclosed measuring cup designed
    for use with this product. Do not use any
    other dosing device.

    adults and children 12 years and over                            • take 2 tablespoons (tbsp) or 1 oz in dose cup
                                                                                                     provided every 4 to 6 hrs while symptoms last
    children under 12 years                                                     • do not take more than 8 tablespoons (tbsp) or
                                                                                                     4 oz in 24 hrs
                                                                                                  • do not take more than 10 days unless directed
                                                                                                    by a doctor
                                                                                                  • do not use this adult product in children under
                                                                                                    12 years of age; this will provide more than the
                                                                                                    recommended dose (overdose) and may
                                                                                                    cause liver damage

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  • Other Information

    each tablespoon contains: sodium 9 mg
    • store at controlled room temperature
    • dosage cup provided

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  • Inactive Ingredients

    citric acid, flavors, high fructose corn syrup,
    polyethylene glycol, propylene glycol,
    purified water, red 33, red 40, saccharin
    sodium, sodium benzoate, sorbitol

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  • Principal Display Panel

    CVS Pharmacy
    Extra Strength Pain Relief
    Adult Liquid
    Acetaminophen   Pain Reliever, Fever Reducer
    Rapid Burst Cherry Flavor
    8 fl oz (237 mL)

    image of  label


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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOHPEN  ADULT RAPID BURST CHERRY
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-550
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 500 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    HIGH FRUCTOSE CORN SYRUP  
    POLYETHYLENE GLYCOL 300  
    PROPYLENE GLYCOL  
    WATER  
    D&C RED NO. 33  
    FD&C Red No. 40  
    SACCHARIN SODIUM ANHYDROUS  
    SODIUM BENZOATE  
    SORBITOL  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Tynelol Type Cherry Rapid Blast Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-550-88 237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/02/2009
    Labeler - CVS (062312574)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture, analysis
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