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

  • 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 3, 2021

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:

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

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

    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 beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
    • limit the use of caffeine-containing medications, foods, or beverages while taking this product 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 over:
      • take 2 caplets with water
      • repeat every 6 hours, as needed
      • do not exceed 6 caplets per day
    • children under 12 years: ask a doctor
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    NDC 53943-390-10

    DISCOUNT
    drug
    mart
    FOOD FAIR

    MAXIMUM STRENGTH

    Menstrual
    Complete

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

    MULTI-SYMPTOM RELIEF
    of Cramps, Bloating, Fatigue,
    Backache & Headache

    Actual
    Size

    40
    CAPLETS

    *Compare to the active ingredients in MIDOL® COMPLETE

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

    *This product is not manufactured or distributed by
    Bayer HealthCare LLC, owner of the registered trademark
    MIDOL® COMPLETE.            50844    ORG051739010

    DISTRIBUTED BY: DRUG MART - FOOD FAIR
    211 COMMERCE DRIVE, MEDINA, OH 44256
    www.discount-drugmart.com

    SATISFACTION GUARANTEED
    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
    TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
    STORE, SEND REASON FOR DISSATISFACTION, NAME,
    ADDRESS AND EMPTY PACKAGE TO:
    DISCOUNT DRUG MART
    211 COMMERCE DRIVE, MEDINA, OHIO 44256

    Drug Mart 44-390

    Drug Mart 44-390

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    acetaminophen, caffeine, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-390
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;390
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-390-101 in 1 CARTON01/07/2020
    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 finalpart34301/07/2020
    Labeler - Discount Drug Mart (047741335)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(53943-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(53943-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(53943-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(53943-390)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(53943-390)