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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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
  • PRINCIPAL DISPLAY PANEL

    100R 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

    100R Green Guard Ibuprofen Label
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  • INGREDIENTS AND APPEARANCE
    GREEN GUARD IBUPRO RELIEF 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:47682-029
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (Ibuprofen) Ibuprofen 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    CROSCARMELLOSE SODIUM  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    POLYVINYL ALCOHOL  
    SILICON DIOXIDE  
    STARCH, CORN  
    TALC  
    TITANIUM DIOXIDE  
    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
    GREEN GUARD IBUPRO RELIEF 
    ibuprofen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:47682-014
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ibuprofen (Ibuprofen) Ibuprofen 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    POVIDONE  
    SILICON DIOXIDE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    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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