MIDOL LONG LASTING RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]

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MIDOL LONG LASTING RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [BAYER HEALTHCARE LLC.]
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NDC 0280-8090-20
Set ID 4a3a711d-c882-3525-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC.
Generic Name
Product Class
Product Number
Application Number ANDA075077
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)

    Acetaminophen 650 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • Uses

    Uses

    • Temporarily relieves minor aches and pains due
    • muscular aches
    • backache
    • minor pain of athritis
    • toothache
    • premenstrual and mentrual cramps
    • headache
    • the common cold
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Liver warning: The product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy Alert: Acetaminophen may cuse 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

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
    • If you are allergic to acetaminophen or any of the inactive ingredients in this product.
  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    As a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

  • STOP USE

    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

  • 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.

    Overdose warning: In 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

    Directions

    • do not take more than directed (see overdose warning)
    adults and children 12 years and over
    • take 2 caplets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 caplets in 24 hours
      • do not use for more than 10 days unless directed by a doctor
    children under 12 years
    • do not use

  • Other information

    Other information

    • store at 20-25° (68-77°F). Avoid excessive heat 40°C (104°F).
    • do not use if printedfoil under cap is broken or missing
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycolpolysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments

    Questions or comments? 1-800-331-4536

  • PRINCIPAL DISPLAY PANEL

    20 count carton

  • INGREDIENTS AND APPEARANCE
    MIDOL LONG LASTING RELIEF 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code MLLR
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-8090-201 in 1 CARTON03/10/2017
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07507703/10/2017
    Labeler - Bayer HealthCare LLC. (112117283)
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