Label: DOLEX FEM- acetaminophen, caffeine, pyrilamine maleate tablet, coated

  • NDC Code(s): 55758-326-02, 55758-326-25, 55758-326-50
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Drug Facts

  • Active ingredients & Purposes

    Active ingredients (in each caplet)Purposes
    Acetaminophen 500mg............................Pain reliever
    Caffeing 60mg .........................................Diuretic
    Pyrilamine maleate 15mg.........................Anthistamine
  • Uses

    For the temporary relief of these symptoms associated with menstrual periods

    • cramps
    • bloating
    • water- weight gain
    • headache
    • backache
    • Muscle aches
    • fatigue
  • Warnings

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

    • more than 6 caplets in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.

    Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 beat.

    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.
    • for more than 10 days for pain unless directed by a doctor
    • if allergic to any of the ingredients in this product

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • may cause excitability in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain persist or gets worse

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of an 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 exceed recommended dose
    • take every 6 hours. Do not exceed 6 caplets in a 24-hour period
      • adults and children 12 years of age and over: take two (2) tablets, every 6 hours
      • children under 12 years of age: do not use
  • Other information

    • Store at room temperature 77-86°F (25-30°C)
  • Inactive ingredients

    corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k30, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-866-359-3478 (M-F) 9AM - 5PM or www.pharmadel.com

    *This product is not manufactured or distributed by Bayer Healthcare LLC owner of the registered trademark MidolⓇ Complete.

  • Prinicpal Display Panel

    Compare to MidolⓇ Complete active ingredients*

    Dolex Fem

    Menstrual Complete

    Acetaminophen, Caffeine, Pyrilamine Maelate

    NDC 55758-326-25

    PDP 24ct

    NDC 55758-326-02

    PDP 25x2

    NDC 55758-326-50

    PDP 25x2 Display

  • INGREDIENTS AND APPEARANCE
    DOLEX FEM 
    acetaminophen, caffeine, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-326
    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
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code HH7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-326-251 in 1 CARTON10/01/2020
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:55758-326-5025 in 1 BOX04/07/2023
    2NDC:55758-326-022 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:55758-326-022 in 1 PACKET; Type 0: Not a Combination Product04/07/2023
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/01/2020
    Labeler - Pharmadel LLC (030129680)
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