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Pill Identifier Information of Ibuprofen 200 MG Oral Capsule

Drug Information

Ibuprofen 200 MG Oral Capsule

Imprint: A;77
Shape: C48336
Color: C48334
Ingredients: Ibuprofen
Size: 8.00
Score: 1
Rxtty: SCD
Author: Amneal Pharmaceuticals
Inactive Ingredients: D&C YELLOW NO. 10 / FD&C BLUE NO. 1 / GELATIN / POLYETHYLENE GLYCOL / WATER / POTASSIUM HYDROXIDE / SORBITOL>

Complete Information

  • OTC - ACTIVE INGREDIENT

    (in each capsule)

    Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

    (present as the free acid and potassium salt)

    * nonsteroidal anti-inflammatory drug

  • OTC - PURPOSE

    Pain reliever/Fever reducer

  • INDICATIONS AND USAGE

    • 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 a nonsteroidal anti-inflammatory drug (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
  • OTC - 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
  • OTC - ASK DOCTOR

    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
  • OTC - ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

  • OTC - WHEN USING

    When using this product

  • OTC - STOP USE

    Stop use and ask a doctor if

  • OTC - 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.

  • OTC - 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 (1-800-222-1222) right away.

  • DOSAGE AND ADMINISTRATION

    DIRECTIONS

  • OTHER INFORMATION

  • INACTIVE INGREDIENTS

    D&C Yellow # 10, FD&C Blue # 1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

  • OTC – QUESTIONS OR COMMENTS?

    Call 1-877-835-5472 Monday through Friday 9AM - 5PM EST

    READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

    Do Not Use if printed foil under cap is broken or missing.

    Distributed by:  Amneal Pharmaceuticals

    Glasgow, KY  42141

    Rev. 08-2011

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    1f80343c-figure-01

    1f80343c-figure-021f80343c-figure-03

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN PAIN RELIEVER/FEVER REDUCER 
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorturquoiseScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code A;77
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-770-021 in 1 CARTON12/23/2011
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:65162-770-691 in 1 CARTON12/23/2011
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65162-770-50500 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2011
    4NDC:65162-770-111000 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20230012/23/2011
    Labeler - Amneal Pharmaceuticals LLC (123797875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amneal Pharmaceuticals of New York, LLC123797875analysis(65162-770, 65162-770) , label(65162-770, 65162-770) , manufacture(65162-770, 65162-770) , pack(65162-770, 65162-770)