Label: GREEN GUARD IBUPRO RELIEF- ibuprofen tablet, film coated

  • NDC Code(s): 47682-014-33, 47682-014-48, 47682-014-99, 47682-029-33, view more
    47682-029-48, 47682-029-99
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    Temporarily relieves minor aches and pains associated with

    • headache
    • toothache
    • backache
    • menstrual cramps
    • common cold
    • muscular aches
    • minor arthritis pain

    Temporarily reduces fever.

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  • Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

    Ask a doctor before use if

    • you have problems or serious side effects from taking pain relievers or fever reducers
    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you have asthma
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs
    • the risk of heart attack or stroke may increase if you use more than directed or longer than directed

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present in the painful area
    • any new or unexpected symptoms occur

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not use more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)

    Adults and children: (12 years and older)

    Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
    Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

    Children under 12 years:

    Do not give to children under 12 years of age.

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  • Other information

    • read all product information before using
    • store at 68-77°F (20-25°C)
    • avoid excessive heat 40°C (above 104°F)
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

    carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin*

    *may contain

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  • Questions or comments? 1-800-869-6970
  • 029 Green Guard Ibuprofen Label

    Ibupro relief

    Compare active ingredient to Advil®

    Green Guard®

    Pull Out

    Ibuprofen 200 mg/Ibuprofeno 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    Alivia el Dolor/ Reduce la Fiebre (AINE)

    Advil® is a Registered Trademark of Pfizer Consumer Healthcare

    125 packets of 2 Tablets

    250 Tablets

    Order# 2251

    Distributed by Green Guard®

    St. Louis, MO 63045

    Green Guard Ibuprofen

    Close
  • 014 Green Guard Ibupro Relief

    Ibupro relief

    Compare active ingredient to Advil®

    Green Guard®

    Pull Out

    Ibuprofen 200 mg/Ibuprofeno 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    Alivia el Dolor/ Reduce la Fiebre (AINE)

    Advil® is a Registered Trademark of Pfizer Consumer Healthcare

    125 packets of 2 Tablets

    250 Tablets

    Order# 2251

    Distributed by Green Guard®

    St. Louis, MO 63045

    Green Guard Ibupro Relief

    Close
  • INGREDIENTS AND APPEARANCE
    GREEN GUARD IBUPRO RELIEF 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-029
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code 115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-029-48 125 in 1 BOX, UNIT-DOSE
    1 NDC:47682-029-99 2 in 1 PACKET
    2 NDC:47682-029-33 50 in 1 BOX, UNIT-DOSE
    2 NDC:47682-029-99 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091237 06/25/2012 11/01/2013
    GREEN GUARD IBUPRO RELIEF 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-014
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code 44;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-014-48 125 in 1 BOX, UNIT-DOSE
    1 NDC:47682-014-99 2 in 1 PACKET
    2 NDC:47682-014-33 50 in 1 BOX, UNIT-DOSE
    2 NDC:47682-014-99 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075139 12/30/2008
    Labeler - Unifirst First Aid Corporation (832947092)
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