Label: HEALTHY MAMA SHAKE THAT ACHE- acetaminophen tablet

  • 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 18, 2013

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purposes

    Pain reliever/fever reducer

  • Uses

    • for the temporary relief of 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
  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen 
    • 3 or more alcoholic drinks every day while using this product

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 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.


    If pregnant or breast-feeding, ask a health professional before use.

    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 for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • Do not take more than directed (see overdose warning)

    Adults and children 12 years and over:

    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor

    Children under 12 years: ask a doctor

  • Other information

    • Do not use if imprinted safety seal under cap is broken or missing.
    • Store at room temperature
  • Inactive ingredients

    Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

  • Questions?

    If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx.

  • Principal Display Panel

    healthy

    mama

    SHAKE THAT ACHE!

    EXTRA STRENGTH PAIN RELIEVER

    aspirin free

    100 caplets( 500 mg each)


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  • INGREDIENTS AND APPEARANCE
    HEALTHY MAMA  SHAKE THAT ACHE
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58154-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (capsule shaped tablet) Size18mm
    FlavorImprint Code GPI;A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58154-100-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/18/2013
    Labeler - MATERNAL SCIENCE, LLC (078722406)
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