EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [MECHANICAL SERVANTS LLC]

EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET [MECHANICAL SERVANTS LLC]
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NDC 29485-7626-6
Set ID c08f5ac3-b2cf-44e8-9e38-259addf61abd
Category HUMAN OTC DRUG LABEL
Packager Mechanical Servants LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET-

    Acetaminophen 500 mg

  • PURPOSE

    Analgesic, Antipyretic (fever reducer)

  • INDICATIONS & USAGE

    Uses: temporarily relieves minor aches and pains due to: • headache • common cold • toothache • backache • muscular aches • menstrual cramps • minor arthritis pain

    Temporarily reduces fever

  • WARNINGS

    Warnings:

    Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 8 tablets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen (prescription or non-prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. • you have 3 or more alcoholic drinks every day while using this product

    Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening

    • blisters

    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use: • with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

    When using this product do not exceed recommended dose.

    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 or fever persists or 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years: consult a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, hydroxypropyl methylcelluslose*, maltodextrin*, polyethylen glycol*, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

    *contains one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    Extra Strength

    PAIN RELIEVER

    Acetaminophen

    Pain Reliever / Fever Reducer

    COMPARE TO THE ACTIVE INGREDIENTS IN

    TYLENOL ® EXTRA STRENGTH*

    6 TABLETS

    ES Pain Reliever

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7626
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7626-63 in 1 PACKET03/15/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/15/2019
    Labeler - Mechanical Servants LLC (005530951)

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