Label: MENSTRUAL RELIEF MAXIMUM STRENGTH MULTI SYMPTOM- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

  • NDC Code(s): 70000-0145-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 23, 2023

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  • Active ingredients (in each caplet)

    Acetaminophen 500 mg
    Pamabrom 25 mg
    Pyrilamine maleate 15 mg

  • Purpose

    Pain reliever
    Diuretic
    Antihistamine 

  • Uses

    for the temporary relief of these symptoms associated with menstrual periods:

    • headache
    • bloating
    • cramps
    • backache
    • muscular aches
    • irritability
    • 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
    • excitability may occur, especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery 

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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 accidental 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 every 6 hours as needed
      • do not exceed 6 caplets in a 24 hour period or as directed by a doctor
    • children under 12 years: ask a doctor
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    LEADER™

    NDC 70000-0145-1

    Maximum Strength Multi-Symptom

    Menstrual Relief
    Acetaminophen | Pamabrom | Pyrilamine maleate
    Pain Reliever | Diuretic | Antihistamine

    Relieves:
    Cramps, Bloating, Irritability,
    Headache and Backache

    20 CAPLETS

    ACTUAL SIZE

    COMPARE TO MAXIMUM STRENGTH PAMPRIN® MULTI-SYMPTOM active ingredients*

    100% Money Back Guarantee

     TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Focus Consumer Healthcare, LLC, owner of the registered trademark Maximum Strength Pamprin® Multi-Symptom.

    50844        REV0718A67909

    CardinalHealth™  

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com   1-800-200-6313
    Essential to Care™ since 1979

    © 2019 Cardinal Health. All Rights Reserved.
    CARDINAL HEALTH, the Cardinal Health LOGO,
    LEADER, and the Leader LOGO are trademarks
    or registered trademarks of Cardinal Health.

     100% Money Back Guarantee
    Return to place of purchase.

    Leader 44-679

    Leader 44-679

  • INGREDIENTS AND APPEARANCE
    MENSTRUAL RELIEF  MAXIMUM STRENGTH MULTI SYMPTOM
    acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 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)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;679
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0145-11 in 1 CARTON01/13/2015
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/13/2015
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0145)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(70000-0145)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(70000-0145)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(70000-0145)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0145)
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