Label: CHILDRENS CHEWABLE ACETAMINOPHEN - acetaminophen tablet, chewable 

  • Label RSS
  • NDC Code(s): 51645-711-30
  • Packager: Gemini Pharmaceuticals, Inc. dba Plus Pharma
  • 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 12/10

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

  • Active Ingredients (in each chewable tablet)

    Acetaminophen 80 mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Uses

    Temporarily relieves minor aches and pain due to:

    ■ The common cold  ■ Flu  ■ Headache  ■ Sore throat

    ■ Toothache

    Temporarily reduces fever.

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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.

    Do not use ■ with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
    ■ If your child is allergic to acetaminophen or any of the inactive ingredients in this products.


    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.

    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 the 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 products does not contain directions or complete warning for adult use.
    ■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
    ■ Chew before swallowing
    ■ If needed, repeat dose every 4 hours while symptoms lasts
    ■ Do not give more than 5 times in 24 hours
    ■ Do not give for more than 5 days unless directed by a doctor.


    WEIGHT AGE TABLETS
    Under 24 lbs
    Under 2 years
    Ask a doctor
    24-35 lbs
    2-3 years
    2 tablets
    36-47 lbs
    4-5 years
    3 tablets
    48-59 lbs
    6-8 years
    4 tablets
    60-71 lbs
    9-10 years
    5 tablets
    72-95 lbs
    11 years
    6 tablets

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  • Other Information

    • Phenylketonurics: Contain phenylalanine 14 mg per tablet
    • Store at room temperature in a dry place
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  • Inactive Ingredients


    Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.
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  • Questions?

    If you have any questions or comments, or to report an adverse drug event, please contact (800) 795-9775.

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  • Principal Display Panel

    See New Warning Information

    PlusPHARMATM

    Children's Chewable

    ACETAMINOPHEN

    PAIN RELIEVER/FEVER REDUCER

                    CONTAINS NO ASPIRIN

    *Compare the active ingredients to  Children Chewable Tylenol®

    30 Chewable Tablet    ■ 80 mg EachPharma Plus Children's chewable Acetaminophen 80mg

    Rev. 06/10

    Do not use if imprinted seal under cap is broken or missing.

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51645-711
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    SILICON DIOXIDE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MANNITOL  
    POVIDONE  
    STARCH, CORN  
    SODIUM CHLORIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    SORBITOL  
    STEARIC ACID  
    SUCRALOSE  
    Product Characteristics
    Color pink Score no score
    Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
    Flavor Imprint Code 1G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51645-711-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 12/03/2010
    Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
    Establishment
    Name Address ID/FEI Business Operations
    Gemini Pharmaceuticals, Inc. dba Plus Pharma 055942270 manufacture
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