IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [MECHANICAL SERVANTS LLC]

IBUPROFEN (IBUPROFEN 200MG) TABLET, FILM COATED [MECHANICAL SERVANTS LLC]
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NDC 29485-7625-6
Set ID 8fc65767-1783-4f7f-8680-9e43ba4d5481
Category HUMAN OTC DRUG LABEL
Packager Mechanical Servants LLC
Generic Name
Product Class
Product Number
Application Number ANDA079174
  • ACTIVE INGREDIENT

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

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses:

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

    • 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 • rash • blisters

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

    Stomach Bleeding Warning: This product contains a 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 presrciption 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.

    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 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 • high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke

    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: • 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

    • 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:

    • chst pain • trouble breathing •weakness in one part or side of body • slurred speech • leg swelling

  • 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 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    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 of age: ask a doctor

  • INACTIVE INGREDIENT

    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

    IBUPROFEN BLISTERIBUPROFEN FACEPLATEIBUPROFEN BLISTERIBUPROFEN FACEPLATE

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen 200mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7625
    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)  
    HYPROMELLOSE 2208 (4000 MPA.S) (UNII: 39J80LT57T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    TRIACETIN (UNII: XHX3C3X673)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7625-63 in 1 PACKAGE03/13/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917403/13/2019
    Labeler - Mechanical Servants LLC (005530951)

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