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

  • NDC Code(s): 0280-8005-01, 0280-8005-02, 0280-8005-16, 0280-8005-24, view more
    0280-8005-40
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever
    Caffeine 60 mgDiuretic
    Pyrilamine maleate 15 mgAntihistamine
  • Uses

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

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

  • 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
  • Other information

    store at room temperature

  • 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

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 40 Caplet Bottle Carton

    Midol Complete Caplet 40ct CartonVALUE SIZE

    Midol ®

    Complete

    Acetaminophen/Caffeine/Pyrilamine Maleate

    Pain Reliever/Diuretic/Antihistamine

    MAXIMUM STRENGTH

    MULTI-SYMPTOM

    RELIEF OF

    CRAMPS, BLOATING

    FATIGUE, BACKACHE

    & HEADACHE

    40 CAPLETS

  • INGREDIENTS AND APPEARANCE
    MIDOL COMPLETE 
    acetaminophen, caffeine, and pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVAL (oblong) Size17mm
    FlavorImprint Code MIDOL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-8005-162 in 1 CARTON02/10/2014
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0280-8005-243 in 1 CARTON02/10/2014
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0280-8005-401 in 1 CARTON02/10/2014
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-8005-0110 in 1 CARTON04/26/2023
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:0280-8005-0225 in 1 CARTON04/26/2023
    52 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02702/10/2014
    Labeler - Bayer HealthCare LLC. (112117283)