Label: LEADER PREMENSTRUAL- acetaminophen, pamabrom, pyrilamine maleate capsule

  • Category: HUMAN OTC DRUG LABEL

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 February 29, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients (in each caplet)

    Acetaminophen 500mg
    Pamabrom 25mg
    Pyrilamine Maleate 15mg

    Purpose

    Pain Reliever
    Diuretic
    Antihistimine/Diuretic

  • Uses

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

    • cramps
    • bloating
    • breast tenderness
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks everyday while using this product
    Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems. 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. Do not exceed recommended dose.

    Do not use

    • with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, as a doctor or pharmacist.

    As a doctor before use if you have

    • liver disease
    • glaucoma
    • difficulty in urination due to an 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 sedatives or tranquilizers
    • taking the blood thinning drug warfarin

    When using this product

    • you may get drowsy
    • excitability may occur especially in children
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if

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

    Pregnant or breast-feeding

    ask a health professional before use

    Keep out of reach of children.

  • Directions

    • do not take more than the recommended dose (see Overdose warning)
    • adults and children 12 years of age and older: take 2 caplets with water
    • repeat every 6 hours, as needed
    • do not exceed 8 caplets per day
    • children under 12 years of age: consult a doctor


  • Other information

    store at 15-30degreesC (59-86degreesF)

  • Inactive Ingredients

    croscarmellose sodium, hypromellose, magnesium silicate, magnesium stearate, microcrystalline celulose, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin.

  • Questions or comments?

    Call toll free 1-800-200-6313

  • Package labeling

    SEE NEW WARNINGS INFORMATION      NDC 37205-339-62

    Leader Maximum Strength Premenstrual Relief

    Acetaminophen

    Pamabrom, Pyrilamine Maleate

    Relieves: Cramps, Bloating, Tenderness

    24 caplets


    Distributed By Cardinal Health
    Dublin, Ohio 43017
    CIN 3468287
    www.myleader.com 1-800-200-6313

    All Leader brand products are 100% satisfaction guaranteed or return to place of purchase for full refund.


    Leader Premenstrual



    Leader Premenstrual

  • INGREDIENTS AND APPEARANCE
    LEADER PREMENSTRUAL 
    acetaminophen, pamabrom, pyrilamine maleate capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-339
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    PAMABROM (UNII: UA8U0KJM72) (PAMABROM - UNII:UA8U0KJM72) PAMABROM25 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeOVAL (OVAL) Size7mm
    FlavorImprint Code CPC2826
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-339-6224 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/28/2012
    Labeler - Cardinal Health (097537435)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!