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

  • NDC Code(s): 36800-187-24
  • Packager: TOP CARE (Topco Associates LLC)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • Active ingredients (in each caplet)

    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
      • fatigue
      • backache
      • water-weight gain
      • headache
      • muscle aches
  • 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

    • 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

    • drowsiness may occur
    • 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 last more than 3 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.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical 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 take more than 6 caplets in 24 hours
    • children under 12 years: consult a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86º F)
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO MIDOL® COMPLETE ACTIVE INGREDIENTS*

    MAXIMUM STRENGTH SUPPORTING THE FIGHT AGAINST BREAST CANCER†

    Menstrual Relief

    ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

    PAIN RELIEVER • DIURETIC • ANTIHISTAMINE

    MULTI-SYMPTOM RELIEF OF:

    • Cramps
    • Bloating
    • Fatigue
    • Backache 
    • Headache

    CAPLETS

    *This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Midol® Complete.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007 ©TOPCO

    QUESTIONS? 1-888-423-0139

    topcare@topcare.com    

  • Product Label

    Acetaminophen 500 mg, Caffeine 60 mg, Pyrilamine maleate 15 mg

    TOPCARE HEALTH Menstrual Relief

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL RELIEF 
    acetaminophen, caffeine and pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-187
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code TCL347
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-187-2424 in 1 CARTON03/31/201412/31/2024
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01303/31/201412/31/2024
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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