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

  • 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 December 16, 2019

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

  • 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 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 nedical 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 are allergic to acetaminophen or any of the inactive ingredients in this product

    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
    • 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 15ºC- 30ºC (59º- 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 1-877-753-3935 Monday- Friday 9AM-5PM EST

  • Principal Display Panel

    Maximum Strength

    Menstrual Relief Caplets

    Acetaminophen, Caffeine, Pyrilamine maleate

    Pain Reliever / Diuretic / Antihistamine

    Multi-Symptom Relief of:

    Cramps

    Bloating

    Fatigue

    Backache & Headache

    Caplets

    Compare to the active ingredients in Midol® Complete †

    † 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: fred's, Inc.

    4300 NEW GETWELL RD, MEMPHIS, TN 38118

    www.fredsinc.com

  • Product Label

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

    Fred's Menstrual Relief Caplets

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL RELIEF 
    acetaminophen, caffeine and pyrilamine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-183
    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:55315-183-242 in 1 CARTON10/15/201212/30/2021
    112 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 FINALpart34310/15/201212/30/2021
    Labeler - Freds Inc (005866116)