Label: MIDOL COMPLETE GELCAPS- midol complete tablet, coated

  • Category: HUMAN OTC DRUG LABEL

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 13, 2017

If you are a healthcare professional or from the pharmaceutical industry 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

    midolcompletegelcaps

  • 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 not finalpart34312/15/2014
    Labeler - Bayer HealthCare LLC (112117283)