Label: MENSTRUAL COMPLETE- acetaminophen, caffeine, pyrilamine maleate tablet

  • 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 October 2, 2019

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

  • Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Caffeine 60 mg

    Pyrilamine maleate 15 mg

  • Purpose

    Pain reliever

    Diuretic

    Antihistamine

  • Uses

    • for the temporary relief of these symptoms associated with menstrual periods
      • cramps
      • bloating
      • fatigue
      • backache 
      • water-weight gain
      • headache 
      • muscle aches
  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours 
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause 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

    • 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

    • drowsiness may occur
    • 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

    These could be signs of a serious condition.

    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 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 take more than 6 caplets in 24 hours
    • children under 12 years: consult a doctor
  • Other information

    • store at 25ºC (77ºF) excursions permitted between 15º- 30ºC (59º- 86ºF)
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions?

    Or to report an adverse event call 800-824-1706 Monday - Friday 9am 4pm MST

  • Principal Display Panel

    Compare to the active ingredients in MIDOL® Complete 

    Relief of Cramps, Bloating, Fatigue, Backache & Headache

    MAXIMUM STRENGTH

    Menstrual Complete

    ACETAMINOPHEN / PAIN RELIEVER

    CAFFEINE / DIURETIC

    PYRILAMINE MALEATE / ANTIHISTAMINE

    CAPLETS

    *This product is not manufactured or distributed by BAYER HEALTHCARE LLC, distributor of MIDOL® Complete.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

  • Product Label

    Acetaminophen 500 mg, Caffeine 60 mg, Pyrilamine Maleate 15 mg

    WinCo Foods Maximum Strength Menstrual Complete Caplets

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    acetaminophen, caffeine, pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-305
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code TCL347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-305-401 in 1 BOX08/31/201612/30/2020
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34308/31/201612/30/2020
    Labeler - WinCo Foods, LLC (056098817)