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

  • NDC Code(s): 55319-301-21
  • Packager: Family Dollar Services Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 30, 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:

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

    • difficulty in urination due to enlargement of the prostate gland
    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    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 beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • excitability may occur, especially in children
    • use caution when driving a motor vehicle or operating machinery
    • limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate. 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

    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. Prompt 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 directed
    • adults and children 12 years and over:
      • take 2 caplets with water
      • repeat every 6 hours, as needed
      • do not exceed 6 caplets per day
    • children under 12 years: ask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • see end flap for expiration date and lot number
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    FAMILY
    Wellness™

    *COMPARE TO THE
    ACTIVE INGREDIENTS IN
    MIDOL® COMPLETE

    MENSTRUAL COMPLETE

    Acetaminophen - Pain Reliever
    Caffeine - Diuretic
    Pyrilamine maleate - Antihistamine

    MULTI-SYMPTOM RELIEF OF:
    Cramps, Bloating, Fatigue,
    Backache & Headache

    ACTUAL SIZE

    16 CAPLETS

    NDC 55319-301-21

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

    *This product is not manufactured or distributed
    by Bayer HealthCare LLC, owner of the registered
    trademark Midol® Complete.
    50844     ORG062339021

    DISTRIBUTED BY: MIDWOOD BRANDS LLC,
    500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA
    NOT 100% SATISFIED?
    Return within 30 days to the store of purchase
    for a refund (with receipt) or exchange.

    Family Wellness 44-390

    Family Wellness 44-390

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL COMPLETE 
    acetaminophen, caffeine, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-301
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;390
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-301-212 in 1 CARTON01/25/2024
    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 DrugM01301/25/2024
    Labeler - Family Dollar Services Inc (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(55319-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(55319-301) , pack(55319-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(55319-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(55319-301)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(55319-301)
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