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

  • NDC Code(s): 49035-390-08, 49035-390-10
  • Packager: Wal-Mart Stores Inc
  • 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 January 18, 2016

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

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  • Purpose

    Pain reliever
    Diuretic
    Antihistamine

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  • Uses

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

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

    • if you have ever had an allergic reaction to this product or any of its ingredients
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a  doctor or pharmacist.

    Ask a doctor before use if you have

    • difficulty in urination due to enlargement of the prostate gland
    • liver disease
    • glaucoma
    • 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

    • avoid alcoholic beverages
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • you may get drowsy
    • 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.

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  • 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
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  • Other information

    • see end flap for expiration date and lot number
    • store at 25ºC (77ºFº); excursions permitted between 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

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

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  • Questions or comments?

     1-888-287-1915

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  • Principal Display Panel

    equate™

    NDC 49035-390-10

    Compare to Midol® Complete Active Ingredients*

    Maximum Strength
    Menstrual Complete
    Acetaminophen
    , Caffeine, Pyrilamine maleate
    Pain Reliever/Diuretic/Antihistamine

    Relieves:
    • Cramps
    • Bloating
    • Fatigue
    • Backache & Headache

    40
    CAPLETS

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

    Satisfaction guaranteed -
    For questions or comments
    please call 1-888-287-1915

    Distributed by: Wal-Mart Stores, Inc.
    Bentonville, AR 72716.

    *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.
    50844    REV0615C39010
    Equate 44-390

    Equate 44-390

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  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE  MAXIMUM STRENGTH
    acetaminophen, caffeine and pyrilamine maleate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-390
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score 3 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code 44;390
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-390-08 1 in 1 CARTON
    1 24 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:49035-390-10 1 in 1 CARTON
    2 40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 04/29/2002
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-390)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-390)
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