Label: PRE MENSTRUAL RELIEF MAXIMUM STRENGTH- acetaminophen, pamabrom and pyrilamine maleate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • Active Ingredients (in each caplet)

    Acetaminophen 500 mg
    Pamabrom 25 mg
    Pyrilamine Maleate 15 mg

    Purpose

    Pain Reliever
    Diuretic
    Antihistimine/Diuretic

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  • Uses

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

    • cramps
    • bloating
    • breast tenderness
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  • 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, ask a doctor or pharmacist.

    Ask 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 persists for more than 10 days.

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children.

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  • 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
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  • Other information

    • store at 15o-30o C (59o-86o F)
    • *This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Midol®
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  • 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.

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  • Questions or Comments?

    Call toll free 1-877-753-3935

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  • Package label

    *Compare to Midol® Maximum strength Premenstrual Syndrome Formula active ingredients

    See New Warnings Information

    Maximum strength

    Pre- Menstrual Relief

    acetaminophen, pamabrom, pyrilamine maleate

    pain reliever/ Diuretic/ Antihistamine

    Cramps, Bloating, Breast Tenderness

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Good Neighbor Pharmacy

    Pre menstrual relief caplets

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  • INGREDIENTS AND APPEARANCE
    PRE MENSTRUAL RELIEF  MAXIMUM STRENGTH
    acetaminophen, pamabrom, pyrilamine maleate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:46122-021
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    PAMABROM (BROMOTHEOPHYLLINE) PAMABROM 25 mg
    PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM SILICATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POVIDONE K15  
    STARCH, CORN  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code CPC2826
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46122-021-62 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/07/2011
    Labeler - Amerisource Bergen (007914906)
    Registrant - P and L Development of New York Corporation (800014821)
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