GREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]

GREEN GUARD PMS RELIEF (ACETAMINOPHEN, PAMABROM) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-016-33, 47682-016-48, 47682-016-99
Set ID 43949fe7-3764-4d74-959f-8d3ca06fa06e
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Acetaminophen 325 mg

    Pamabrom 25 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

    Diuretic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves headache, bloating, cramps, backache, water-weight gain, muscular aches and pains associated with the menstrual period.

  • 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, which is the maximum daily amount
    • 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

    • 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
    • for more than 3 days for fever unless directed by a doctor

    Ask a doctor before use if you have

    • liver disease

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present

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

    Keep out of reach of children. In case of 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    ​Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years: Ask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, microcrystalline cellulose, povidone, starch, stearic acid, sucrose

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard PMS Label

    PMS relief™

    Pull to Open

    Tire Para Abrir

    Acetaminophen 325 mg/Acetaminofeno 325 mg

    Pamabrom 25 mg

    Tabletas para el alivio

    del syndrome premenstrual

    GREEN GUARD®

    50 Packets of 2 Tablets

    100 Tablets

    Order #2270

    Distributed by Green Guard®, St Louis, MO 63045

    GG PMS

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD PMS RELIEF 
    acetaminophen, pamabrom tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size11mm
    FlavorImprint Code FR;7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-016-3350 in 1 BOX12/30/2008
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-016-48125 in 1 BOX12/30/2008
    2NDC:47682-016-992 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-016-992 in 1 PACKET; Type 0: Not a Combination Product12/30/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)

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