Label: MENSTRUAL COMPLETE tablet, film coated

  • NDC Code(s): 69168-470-06, 69168-470-82
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • Active ingredient(s)

    Acetaminophen 500 mg 
    Caffeine 60 mg 
    Pyrilamine maleate 15 mg 

  • Purpose

    Pain reliever
    Diuretic
    Antihistamine

  • Use(s)

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

  • 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 ■ 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

    ■ drowsiness may occur
    ■ alcohol, sedatives, and tranquilizers may increase
    drowsiness ■ avoid alcoholic beverages
    ■ excitability may occur, especially in children
    ■ use caution 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 heart rate. 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 breastfeeding,

    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.
    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 directed
    ■ 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) ■ use by expiration date on package

  • Inactive ingredients

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

  • Questions/Comments

    1-888-952-0050

  • Principal Display Panel

    Menstrual Complete

    Menstrual Complete

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    menstrual complete tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-470
    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 (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:69168-470-8290 in 1 BOTTLE; Type 0: Not a Combination Product11/05/2024
    2NDC:69168-470-06120 in 1 BOTTLE; Type 0: Not a Combination Product11/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/05/2024
    Labeler - Allegiant Health (079501930)
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