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

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

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 March 10, 2021

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

  • 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.

    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
    • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery
    • 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 a rapid heartbeat.

    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 4 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 4 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

    NDC 55758-326-25

    Compare to MidolⓇ Complete active ingredients*

    Dolex Fem

    Menstrual Complete

    Acetaminophen, Caffeine, Pyrilamine Maelate

    24 Caplets

    Dolex Fem PDP

  • 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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED 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
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/01/2020
    Labeler - Pharmadel LLC (030129680)