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

  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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
    Stimulant
    Diuretic

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  • Uses

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

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

    • more than 8 caplets in 24 hours, which is the maximum daily ammount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinnks every day while using this product

    Do not use

    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, aska  doctor or pharmacist.

    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

    • you may get drowsy
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives and tranqulizers may increase drowsiness
    • 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, occassionally, 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 appear
    • redness or swelling is present
    • pain gets worse or lasts more than 10 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

    Overdose warning: Taking more than the reocmmended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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  • Directions

    • do not take more than the recommended dose
      (see overdose warning)
    • adults and children 12 years and older: take 2 caplets with water. Repeat every 6 hours, as needed. Do not exceed 8 caplets in 24 hours.
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

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

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

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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/Stimulant/Diuertic

    Multi-Symptom Relief of:
    • Cramps
    • Bloating
    • Fatigue
    • Backache & Headache

    40
    CAPLETS

    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    REV0612A39010

    Equate 44-390

    Equate 44-390

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  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    acetaminophen, caffeine and pyrilamine maleate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-390
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    CAFFEINE (CAFFEINE) CAFFEINE 60 mg
    PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE 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
    2 NDC:49035-390-10 1 in 1 CARTON
    2 40 in 1 BOTTLE, PLASTIC
    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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