IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]

IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]
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NDC 65162-356-02, 65162-356-11, 65162-356-50, 65162-356-69
Set ID 877440fc-3afb-4123-a2e6-5cb48c74413c
Category HUMAN OTC DRUG LABEL
Packager Amneal Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number ANDA202300
  • 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

    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

    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.

  • 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, asthma, or had a stroke
    • you are taking a diuretic
  • OTC - ASK DOCTOR/PHARMACIST

    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
  • OTC - WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs
  • OTC - 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 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
  • 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 right away.

  • DOSAGE AND ADMINISTRATION

    Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
    • children under 12 years: ask a doctor
  • OTHER INFORMATION

    • each capsule contains: potassium 20 mg
    • read all warnings and directions before use. Keep carton.
    • store at 20º to 25ºC (68º to 77ºF)
    • avoid excessive heat above 40ºC (104ºF)
  • INACTIVE INGREDIENT

    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 seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.

    Distributed by: 

    Amneal Pharmaceuticals LLC

    Bridgewater, NJ  08807

    *Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®

    Rev. 11-2017-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC-65162-356-02

    Ibuprofen Capsules, 200 mg

    20 Capsules

    Amneal Pharmaceuticals LLC

    10

    30

  • INGREDIENTS AND APPEARANCE
    IBUPROFEN  PAIN RELIEVER/FEVER REDUCER
    ibuprofen capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-356
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code A356
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65162-356-021 in 1 CARTON03/29/2013
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:65162-356-691 in 1 CARTON03/29/2013
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:65162-356-111000 in 1 BOTTLE; Type 0: Not a Combination Product03/29/2013
    4NDC:65162-356-50500 in 1 BOTTLE; Type 0: Not a Combination Product03/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20230003/29/2013
    Labeler - Amneal Pharmaceuticals LLC (123797875)

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