Label: MEDI FIRST PMS RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, coated
MEDI FIRST PLUS PMS RELIEF- acetaminophen, pamabrom, pyrilamine maleate tablet, coated

  • NDC Code(s): 47682-723-36, 47682-723-80, 47682-823-36, 47682-823-80, view more
    47682-823-99
  • Packager: Unifirst First Aid Corporation
  • 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 22, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 500 mg

    Pamabrom 25 mg

    Pyrilamine maleate 15 mg

  • PURPOSE

    Purpose

    Pain reliever

    Diuretic

    Antihistamine

  • INDICATIONS & USAGE

    Uses

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

    ■ headache

    ■ bloating

    ■ cramps

    ■ backache

    ■ muscular aches

    ■ irritability

    ■ water-weight gain

  • 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

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

  • DO NOT USE

    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 DOCTOR

    Ask a doctor before use if you have

    ■ difficulty in urination due to enlargement of the prostate gland

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ liver disease

    ■ glaucoma

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    ■ taking sedatives or tranquilizers

    ■ taking the blood thinning drug warfarin

  • WHEN USING

    When using this product

    ■ drowsiness may occur

    ■ avoid alcoholic beverages

    ■ excitability may occur, especially in children

    ■ alcohol, sedatives and tranquilizers may increase drowsiness

    ■ use caution when driving a motor vehicle or operating machinery

  • STOP USE

    Stop use and ask a doctor if

    ■ pain gets worse or lasts more than 10 days

    ■ fever gets worse or lasts more than 3 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed

    Adults and children: (12 years and over)

    ■ take 2 caplets with water every 6 hours as needed

    ■ do not exceed 6 caplets in a 24 hour period or as directed by a doctor

    Children under 12 years: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    ■ tamper-evident sealed packets

    ■ do not use any opened or torn packets

  • 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

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medi-First®

    PMS Relief

    Pain Reliever • Acetaminophen 500 mg

    Diuretic • Pamabrom 25 mg

    Antihistamine • Pyrilamine maleate 15 mg

    Mestrual Pain Relief

    Pull to Open

    This Package is for Households Without Young Children.

    Tamper Evident Unit Dose Packets

    80 Caplets

    (40 x 2)

    823R MF PMS

  • PRINCIPAL DISPLAY PANEL

    Medi-First®Plus

    PMS Relief

    Pain Reliever • Acetaminophen 500 mg

    Diuretic • Pamabrom 25 mg

    Antihistamine • Pyrilamine maleate 15 mg

    This Package is for Households Without Young Children.

    Pull to Open

    Relief from Menstrual Pain, Water Retention and Bloating

    Tamper Evident Unit Dose Packets

    80 Caplets

    (40 x 2's)

    823RMFP PMS

  • INGREDIENTS AND APPEARANCE
    MEDI FIRST PMS RELIEF 
    acetaminophen, pamabrom, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-823
    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:47682-823-8040 in 1 BOX09/26/2022
    1NDC:47682-823-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-823-3675 in 1 BOX02/01/2023
    2NDC:47682-823-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/26/2022
    MEDI FIRST PLUS PMS RELIEF 
    acetaminophen, pamabrom, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-723
    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:47682-723-8040 in 1 BOX09/26/2022
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-723-3675 in 1 BOX02/01/2023
    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 finalpart34309/26/2022
    Labeler - Unifirst First Aid Corporation (832947092)