Label: FEM-PRIN- acetaminophen, pamabrom, pyrilamine maleate tablet, film coated

  • NDC Code(s): 50332-0145-4, 50332-0145-7
  • Packager: HART Health
  • 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 August 9, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 500 mg

    Pamabrom 25 mg

    Pyrilamine maleate 15 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Diuretic

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    for the temporary relief of minor aches, pain, and water weight gain due to mentrual cycle

  • WARNINGS

    Warnings

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

    ■ more than 4,000 mg of acetaminophen in 24 hours

    ■ with other drugs containing acetaminophen

    ■ 3 or more alcoholic drinks every day while using this product

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

    ■ skin reddening

    ■ blisters

    ■ rash

  • DO NOT USE

    Do not use

    ■ with any other drug containing acetaminophen (prescription or nonprescription).

  • ASK DOCTOR

    Ask a doctor before use if you have

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ trouble urinating due to an enlarged prostate gland

    ■ liver disease

    ■ glaucoma

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if 

    ■ you do not know if other drugs you are taking contain acetaminophen

    ■ you are taking sedatives or tranquilizers

    ■ you are taking the blood thinning drug warfarin

  • WHEN USING

    When using this product

    ■ drowsiness may occur

    ■ avoid alcoholic beverages

    ■ alcohol, sedatives and tranquilizers may increase drowsiness

    ■ use caution when driving a motor vehicle or operating machinery

    ■ excitability may occur, especially in children

  • STOP USE

    Stop use and ask a doctor if

    ■ an allergic reaction occurs, seek medical help right away

    ■ fever worsens or lasts more than 3 days

    ■ pain worsens or lasts more than 10 days

    ■ new symptoms occur

    ■ redness or swelling is present

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions

    Do not take more than directed

    Adults and children 12 years of age and over

    ■ take 2 caplets every 6 hours while symptoms persist

    ■ do not take more than 6 caplets in 24 hours unless directed by a doctor

    Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ caplets enclosed in a sealed packet

    ■ do not use if packet is torn, cut or open

    ■ store at 59° to 86°F (15°-30°C)

    ■ avoid excessive heat and humidity

  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Femprin.jpg

  • INGREDIENTS AND APPEARANCE
    FEM-PRIN 
    acetaminophen, pamabrom, pyrilamine maleate tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULE (Caplet) Size17mm
    FlavorImprint Code 44;679
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0145-440 in 1 BOX01/09/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0145-7100 in 1 BOX01/09/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/09/2023
    Labeler - HART Health (069560969)