Label: MENSTRUAL COMPLETE GELCAPS- acetaminophen, caffeine, pyrilamine maleate tablet, 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 July 22, 2023

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

  • Drug Facts

  • Active ingredients (in each gelcap)

    Acetaminophen 500 mg
    Caffeine 60 mg
    Pyrilamine maleate 15 mg

  • Purposes

    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 gelcaps 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 severe skin or severe allergic reactions.
    Symptoms may include: • hives • blisters • rash • skin reddening • facial swelling • asthma (wheezing) • shock
    If a skin or general allergic 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
    • 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 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.

    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

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

    Keep out of reach of children.
    Overdose warning: 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 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 gelcaps with water • repeat every 6 hours as needed • do not exceed 6 gelcaps per day
    • children under 12 years: consult a doctor

  • Other information

    each gelcap contains: sodium 3 mg (very low sodium)
    Store at room temperature. Avoid excessive heat above 40°C (104°F).

  • Inactive ingredients

    croscarmellose sodium, D&C red #33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone K30, pregelatinized starch, purified water, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

  • Questions or comments?

    1-888-577-8033 Monday - Friday 8am - 4pm EST

  • SPL UNCLASSIFIED SECTION

    Compare to active ingredients of Midol® Complete*

    DG™ health

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

    READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.

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

    DISTRIBUTED BY: OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

    PRODUCT OF UNITED ARAB EMIRATES

  • Packaging

    MenstrualComp

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE GELCAPS 
    acetaminophen, caffeine, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-960
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorblueScoreno score
    ShapeRECTANGLESize18mm
    FlavorImprint Code S79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-960-243 in 1 CARTON01/25/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/25/2023
    Labeler - Dolgencorp Inc (068331990)