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

  • NDC Code(s): 72090-026-02
  • Packager: Pioneer Life Sciences, LLC
  • 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 May 17, 2021

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

  • Active Ingredient

    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
    water-weight gain
    headache
    backache
    muscle aches
    fatigue

  • Warnings:

    Liver warning

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

    • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert:

    Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:

    • skin reddening
    • blister
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock if a skin or general allergic reaction ocurs, 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 Doctor:

    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 DOCTOR/PHARMACIST:

    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 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.

  • PREGNANCY

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Overdose Warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 older:

    take 2 caplets with water
    repeat every 6 hours, as needed
    do not exceed 6 caplets per day

    children under 12 years: consult a doctor

  • OTHER INFORMATION

    store at room temperature

  • INACTIVE INGREDIENTS

    carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

  • QUESTIONS OR COMMENTS?

    Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

  • 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

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    acetaminophen, caffeine, pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-026
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIACETIN (UNII: XHX3C3X673)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SHELLAC (UNII: 46N107B71O)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize27mm
    FlavorImprint Code CH
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-026-0240 in 1 BOTTLE; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/17/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)