Label: SUNMARK JUNIOR RAPID MELTS- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 7, 2014

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  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/ fever reducer

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  • Uses

    temporarily relieves minor aches and pains due to:

    • the common cold
    • flu
    • headache
    • temporarily reduces fever
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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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 product containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
    • 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 dose (see overdose warning)

    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: Thaking 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. 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 dose
    • do not give more than directed (see overdose warning)
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • dissolve in mouth, or chew before swallowing
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor.
     Weight (lb)  Age (yr)  Tablets
     under 48 lbs  under 6 years  ask a doctor
     48-59 lbs  6-8 years  2
     60-71 lbs  9-10 years  2 1/2
     72-95 lbs  11 years  3

    Other information
    • store at controlled room temperature betweeen 20-25oC(68-77oF)
    • see end flap for expiration date and lot number

    Inactive ingredients

    acesulfame pottasium, citric acid, D&C red 27 aluminum lake, dextrose, FD&C blue 1 aluminum lake, flavors, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose powder, polyplasdone, sorbitol, sucralose.

    May contain ethylcellulose, gelatin, sodium polyphosphate, silicon dioxide.

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  • PDP

    Sunmark

    Junior Rapid Melts

    Compare to JR. Tylenol Meltaways active ingredient

    Pain reliever

    Fever reducer

    Acetaminophen

    Pain reliever/Fever Reducer

    For ages 6-11 years

    Bubblegum Flavor

    24 TabletsBox

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  • INGREDIENTS AND APPEARANCE
    SUNMARK JUNIOR RAPID MELTS 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-063
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 68401960MK)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    Product Characteristics
    Color pink Score no score
    Shape ROUND Size 16mm
    Flavor BUBBLE GUM Imprint Code G220
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-063-04 4 in 1 CARTON
    1 6 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 08/01/2013
    Labeler - Mckesson (177667227)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    Name Address ID/FEI Business Operations
    Guardian Drug Company 119210276 manufacture(49348-063)
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