GREEN GUARD IBUPROFEN RELIEF (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID]

GREEN GUARD IBUPROFEN RELIEF (IBUPROFEN) TABLET, COATED [UNIFIRST FIRST AID]
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NDC 47682-710-33, 47682-710-48, 47682-710-99
Set ID 0798e401-8247-2fce-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Unifirst First Aid
Generic Name
Product Class
Product Number
Application Number ANDA079174
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID*)

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor aches and pains associated with

    ■ headache ■ toothache ■ backache ■ menstrual cramps

    ■ common cold ■ muscular aches ■ minor arthritis pain

    Temporarily reduces fever.

  • WARNINGS

    Warnings

  • SPL UNCLASSIFIED SECTION

    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.

  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

  • DO NOT USE

    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 DOCTOR

    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, kidney disease, asthma or had a stroke

    ■ you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    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

    When using this product

    ■ take with food or milk if stomach upset occurs

  • STOP USE

    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

    ■ you have symptoms of heart problems or stroke

    ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling

    ■ 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

  • PREGNANCY OR BREAST FEEDING

    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

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

  • DOSAGE & ADMINISTRATION

    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: Ask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    ■ read all product information before using

    ■ store at 68-77°F (20-25°C)

    ■ avoid excessive heat 104°F (above 40°C)

    ■ tamper evident sealed packets

    ■ do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients

    carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

    *may contain

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Ibupro Relief

    Ibupro relief™

    Compare active ingredient to Advil®

    Green Guard®

    Pull To Open

    Tire Para Abrir

    Ibuprofen 200 mg/Ibuprofeno 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

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD IBUPROFEN RELIEF 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-710
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (REDDISH BROWN) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-710-3350 in 1 BOX01/26/2017
    1NDC:47682-710-992 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-710-48125 in 1 BOX01/26/2017
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/26/2017
    Labeler - Unifirst First Aid (832947092)

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