FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [HEALTHLIFE OF USA LLC]

FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [HEALTHLIFE OF USA LLC]
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NDC 69517-111-02, 69517-111-05, 69517-111-10, 69517-111-25, 69517-111-30, 69517-111-50
Set ID a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65
Category HUMAN OTC DRUG LABEL
Packager HealthLife of USA LLC
Generic Name
Product Class
Product Number
Application Number ANDA079174
  • Active ingredient(in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/Fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis
    • temporarily reduces fever
  • Warnings

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

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

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

    Ask a doctor or pharmacist before use if you are

    • under a doctor’s care for any serious condition
    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • 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 for 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 more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present in the painful area
    • any new symptoms appear

    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 definitely 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.

  • Directions:

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: 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
  • Other information

    • each tablet contains: sodium 0.030 mg
    • store at 20° to-25°C (68° to-77°F)

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

    • read all product information before using

    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Inactive ingredients

    colloidal silicon dioxide, corn starch. hypromellose, iron oxide red, lactose monohydrate, povidone k30, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

  • Questions or Comments

    Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN Advil®†

    Ibuprofen 200 mg

    Pain Reliever/Fever Reducer (NSAID)

    †This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®

    Untitled.jpg

  • INGREDIENTS AND APPEARANCE
    FAST PAIN RELIEF 
    ibuprofen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-111-2525 in 1 CARTON04/06/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69517-111-5050 in 1 CARTON04/06/2016
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:69517-111-022 in 1 POUCH04/06/2016
    32 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:69517-111-101000 in 1 BOTTLE04/06/2016
    4NDC:69517-111-05500 in 1 BOTTLE
    4NDC:69517-111-3030 in 1 BOTTLE
    41 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/01/2011
    Labeler - HealthLife of USA LLC (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(69517-111)

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