IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [ADVANCED FIRST AID, INC.]

IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [ADVANCED FIRST AID, INC.]
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NDC 67060-001-67, 67060-001-68
Set ID 564e9910-b491-4129-a4f1-68216267623b
Category HUMAN OTC DRUG LABEL
Packager ADVANCED FIRST AID, INC.
Generic Name
Product Class
Product Number
Application Number ANDA079174
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)

  • PURPOSE

    pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses:

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

  • WARNINGS

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

    Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID [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.

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

    Ask a doctor use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain •

    ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older

    Ask a doctor or pharmacist before use if you are: • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug

    taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin

    When using this product: • take with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke

    Stop use and ask a doctor if: • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • redness or swelling is present in the painful area • any new symptoms appear

  • 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:

    Adults and children 12 years of age and older:

    • do not take more than directed • the smallest effective dose should be used • 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 of age: do not use for children under 12 years of age unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: crosscarmellose sodium*, FD& C Blue #2*, FD& C red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin* *contains one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    ADVANCED IBUPROFENADVANCED IBUPROFEN

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen 200mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-001
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-001-68100 in 1 CARTON04/09/2015
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67060-001-67250 in 1 CARTON04/09/2015
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917404/09/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRANULES INDIA LTD918609236manufacture(67060-001)

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