Label: MENSTRUAL RELIEF- acetaminophen, caffeine and pyrilamine maleate capsule, liquid filled

  • 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 05/11

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

  • Active ingredients

    (in each gelcap)

    Acetaminophen 500 mg

    Caffeine 60 mg

    Pyrilamine maleate 15 mg

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  • Purpose

    Pain reliever

    Stimulant

    Diuretic

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  • Uses

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

    • cramps
    • bloating
    • water-weight gain
    • headache
    • backahe
    • breast tenderness
    • fatigue
    • muscle aches
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  • Warnings

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

    • more than 8 gelcaps in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    Ask a doctor before use if you have

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

    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
    • excitability may occur, especially in children
    • be careful when driving a motor vehicle or operating machinery
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • 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 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 appear
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    Ask a health professional before use.

    Keep out of the reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than the recommended dose (see overdose warning)
    • adults and children 12 years and older: take 2 gelcaps with water. Repeat every 6 hours, as needed. Do not exceed 8 gelcaps in 24 hours.
    • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    black iron oxide, cellulose, crocarmellose sodium, FD&C blue #1, gelatin, hypromellose, magnesium stearate, polyethylene glycol, povidone, silica gel, starch, stearic acid, titanium dioxide

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  • Questions of comments?

    1-800-426-9391

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  • Product Packaging

     NDC 0363-0391-08

    Walgreens

    Compare to Midol® Complete

    active ingredients*

    MAXIMUM STRENGTH

    MENSTRUAL

    RELIEF

    Acetaminophen 500 mg,

    Caffeine 60 mg,

    Pyrilamine maleate 15 mg

    Relief of Menstrual Symptoms:

    • Cramps • Bloating • Fatigue • Headaches • Backaches

    SEE NEW WARNINGS INFORMATION

    Aspirin Free

    GELCAPS

    24 GELCAPS

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

    50844     REV0310J39108

    Distributed by: Walgreen Co.,

    200 Wilmot Rd.,

    Deerfield, IL 60015-4616

    Product Packaging

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  • INGREDIENTS AND APPEARANCE
    MENSTRUAL RELIEF 
    acetaminophen, caffeine, pyrilamine maleate capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0391
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    CAFFEINE (CAFFEINE) CAFFEINE 60 mg
    PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    POWDERED CELLULOSE  
    CROSCARMELLOSE SODIUM  
    FD&C BLUE NO. 1  
    GELATIN  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOL  
    POVIDONE  
    SILICON DIOXIDE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code 44;391
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0391-08 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/14/2001
    Labeler - WALGREEN CO. (008965063)
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