Label: MIDOL COMPLETE GELCAPS- midol complete tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gelcap) Purpose

    Acetaminophen 500 mg..............................………………….Pain reliever

    Caffeine 60 mg……….…………………………………….……..….Diuretic

    Pyrilamine maleate 15 mg……………………………………Antihistamine

  • Purpose

  • INDICATIONS & USAGE

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

    • cramps
    • bloating
    • water-weight gain
    • headache
    • backache
    • muscle ache
    • fatigue
  • WARNINGS

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

    · more than 6 gelcaps 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

    Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    · skin reddening · blisters · rash

    · hives · facial swelling · asthma (wheezing) · shock

    If a skin or general allergic 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 have ever had an allergic reaction to this product or any of its

    ingredients

  • ASK DOCTOR


    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 DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are
    · taking the blood thinning drug warfarin
    · taking sedatives or tranquilizers

  • WHEN USING

    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

    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

  • 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    · do not take more than the recommended dose

    · adults and children 12 years and older:

    · take 2 gelcaps with water

    · repeat every 6 hours, as needed

    · do not exceed 6 gelcaps per day

    · children under 12 years: consult a doctor

  • OTHER SAFETY INFORMATION

    Other information

    · store at room temperature

    · avoid excessive heat 104°F (40°C)

  • INACTIVE INGREDIENT

    Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

  • QUESTIONS

    Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Midol Complete Gelcaps 24ct Carton

  • INGREDIENTS AND APPEARANCE
    MIDOL COMPLETE  GELCAPS
    midol complete tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-8015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorturquoiseScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code MIDOL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-8015-243 in 1 CARTON12/15/2014
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02712/15/2014
    Labeler - Bayer HealthCare LLC (112117283)