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 October 16, 2020

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

View All Sections
  • Active Ingredients

    Acetaminophen 500mg
    Caffeine 60mg
    Pyrilamine maleate 15mg

  • Purpose

    Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

  • 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 tablets 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 warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have

    • Liver disease
    • Glaucoma
    • difficulty in urination due to 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 the blood thinning drug warfarin
    • Taking sedatives or tranquilizers
  • When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout 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 for more than 10 days
    • fever gets worse or lasts for more than 3 days
  • If pregnant or breast-feeding

    Ask a health professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 dosage.
    • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
    • Children under 12 years: Consult a doctor
  • Other Information

    • Store at room temperature
    • TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Colloidal silicon dioxide
    • Hypromellose
    • Magnesium stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Polyvinyl pyrrolidone
    • Pregelatinized starch
    • Titanium dioxide
    • Talc
  • Questions or comments?

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

  • Dolex Fem

    labellabel

  • 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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-326-241 in 1 CARTON10/01/2020
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/01/2020
    Labeler - Pharmadel LLC (030129680)
    Registrant - Pharmadel LLC (030129680)
    Establishment
    NameAddressID/FEIBusiness Operations
    Healthlife of USA LLC079656178manufacture(55758-326)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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