IBUPROFEN SUSPENSION [PROFICIENT RX LP]

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IBUPROFEN SUSPENSION [PROFICIENT RX LP]
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NDC 71205-213-72
Set ID b7565aac-a928-4116-b9af-cf636da4537c
Category HUMAN OTC DRUG LABEL
Packager Proficient Rx LP
Generic Name
Product Class
Product Number
Application Number ANDA209207
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Ibuprofen 100 mg (NSAID)1

    1
    nonsteroidal anti-inflammatory drug
  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    •
    relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
    •
    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 your child:

    •
    has had stomach ulcers or bleeding problems
    •
    takes a blood thinning (anticoagulant) or steroid drug
    •
    takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    •
    takes 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.

    Sore throat warning

    Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

    Do not use

    •
    if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
    •
    right before or after heart surgery

    Ask a doctor before use if

    •
    stomach bleeding warning applies to your child
    •
    child has a history of stomach problems, such as heartburn
    •
    child has problems or serious side effects from taking pain relievers or fever reducers
    •
    child has not been drinking fluids
    •
    child has lost a lot of fluid due to vomiting or diarrhea
    •
    child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
    •
    child has asthma
    •
    child is taking a diuretic

    Ask a doctor or pharmacist before use if the child is

    •
    under a doctor's care for any serious condition
    •
    taking any other drug

    When using this product

    •
    take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    •
    child experiences any of the following signs of stomach bleeding
    •
    feels faint
    •
    vomits blood
    •
    has bloody or black stools
    •
    has stomach pain that does not get better
    •
    child has symptoms of heart problems or stroke:
    •
    chest pain
    •
    trouble breathing
    •
    weakness in one part or side of body
    •
    slurred speech
    •
    leg swelling
    •
    the child does not get any relief within first day (24 hours) of treatment
    •
    fever or pain gets worse or lasts more than 3 days
    •
    redness or swelling is present in the painful area
    •
    any new symptoms appear

    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)

  • Directions

    •
    this product does not contain directions or complete warnings for adult use
    •
    do not give more than directed
    •
    shake well before using
    •
    mL = milliliter
    •
    find right dose on chart. If possible, use weight to dose; otherwise use age.
    •
    use only enclosed dosing cup. Do not use any other dosing device.
    •
    if needed, repeat dose every 6 to 8 hours
    •
    do not use more than 4 times a day
    •
    replace original bottle cap to maintain child resistance
    Dosing Chart
    Weight (lb)Age (yr)Dose (mL)*
    *
    or as directed by a doctor

    under 24

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    5 mL

    36-47 lbs

    4-5 years

    7.5 mL

    48-59 lbs

    6-8 years

    10 mL

    60-71 lbs

    9-10 years

    12.5 mL

    72-95 lbs

    11 years

    15 mL
  • Other information

    •
    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    •
    do not use if carton is opened or if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing
    •
    see bottom panel of carton for lot number and expiration date
  • Inactive ingredients

    acesulfame potassium, berry flavor natural & artificial, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sucrose, xanthan gum

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Relabeled by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    *Compare to the active
    ingredient in Children's
    Motrin® Dye-Free Berry Flavor

    NDC 71205-213-72

    See New Warnings

    For ages 2 to 11 years

    Children's
    Ibuprofen
    Oral Suspension, USP

    100 mg per 5 mL
    Pain reliever / Fever reducer (NSAID)

    Dye - Free
    Alcohol Free

    Lasts
    up to 8 hours

    Berry Flavor

    4 FL OZ
    (120 mL)

    71205-213-72
  • INGREDIENTS AND APPEARANCE
    IBUPROFEN 
    ibuprofen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-213(NDC:51672-2130)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    acesulfame potassium (UNII: 23OV73Q5G9)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    glycerin (UNII: PDC6A3C0OX)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    sodium benzoate (UNII: OJ245FE5EU)  
    water (UNII: 059QF0KO0R)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (WHITE to OFF-WHITE) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-213-721 in 1 CARTON01/01/2019
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20920706/27/2017
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-213) , RELABEL(71205-213)
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