Label: ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 25, 2024

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

  • Drug Facts

  • Active ingredients

    Acetaminophen 500mg

    Caffeine 60mg

    Pyrilamine maleate 15mg

  • Purpose

    Pain reliever

    Diuretic

    Antihistamine

  • Uses

    for the temporary relief of these symptoms associated with menstural 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 beacuse 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 • store at room temperature.

  • 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, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredients in Midol® Complete††

    Aspirin Free

    • Relieves cramps, bloating, fatigue, headaches & backaches

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering.

    DISTRIBUTED BY: WALGREEN CO.
    DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com  
    1-800-925-4733

    ©2023 Walgreen Co.

    PRODUCT OF UNITED ARAB EMIRATES
    PACKAGED AND QUALITY ASSURED IN THE U.S.A.

    ††Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
    ††This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol®.

  • Packaging

    Walgreens Menstrual Complete Pain Relief

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG 
    acetaminophen 500mg caffeine 60mg pyrilamine maleate 15mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2310
    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 ALUMINUM LAKE (UNII: L3FT3LUT29)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorblue (DARK BLUE and LIGHT BLUE) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code S79
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2310-2424 in 1 PACKAGE; Type 0: Not a Combination Product07/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/05/2019
    Labeler - WALGREENS CO. (008965063)