Label: MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet

  • NDC Code(s): 0280-8005-16, 0280-8005-24, 0280-8005-40
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 November 7, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 500 mg Pain reliever
    Caffeine 60 mg Diuretic
    Pyrilamine maleate 15 mg Antihistamine
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  • Uses

    for the temporary relief of these symptoms associated with menstrual periods:

    • cramps
    • bloating
    • water-weight gain
    • headache
    • backache
    • muscle aches
    • fatigue
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  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
    • 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    • liver disease
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

    Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than the recommended dose
    • adults and children 12 years and older:
      • take 2 caplets with water
      • repeat every 6 hours, as needed
      • do not exceed 6 caplets per day
    • children under 12 years: consult a doctor
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  • Other information

    store at room temperature

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  • Inactive ingredients

    carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

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  • Questions or comments?

    1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.com

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  • PRINCIPAL DISPLAY PANEL - 40 Caplet Bottle Carton

    VALUE SIZE

    Midol ®
    Complete

    Acetaminophen/Caffeine/Pyrilamine Maleate
    Pain Reliever/Diuretic/Antihistamine

    MAXIMUM STRENGTH
    MULTI-SYMPTOM
    RELIEF OF

    CRAMPS, BLOATING
    FATIGUE, BACKACHE
    & HEADACHE

    40 CAPLETS

    Principal Display Panel - 40 Caplet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    MIDOL COMPLETE 
    acetaminophen, caffeine, and pyrilamine maleate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8005
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white Score no score
    Shape OVAL (oblong) Size 17mm
    Flavor Imprint Code MIDOL
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0280-8005-16 2 in 1 CARTON 02/10/2014
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0280-8005-24 3 in 1 CARTON 02/10/2014
    2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:0280-8005-40 1 in 1 CARTON 02/10/2014
    3 40 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 02/10/2014
    Labeler - Bayer HealthCare LLC. (112117283)
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