Label: CONCENTRATED IBUPROFEN - ibuprofen suspension 

  • Label RSS
  • NDC Code(s): 27808-007-01, 27808-007-02
  • Packager: Tris Phrama Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT (in each 1.25 mL)

    Ibuprofen 50 mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Pain reliever/Fever reducer

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  • USES

    temporarily:

    ■ reduces fever

    ■ relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

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  • 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 the 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

    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.

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  • DO NOT USE

    ■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer

    ■ right before or after heart surgery

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  • ASK DOCTOR BEFORE USE IF THE CHILD HAS

    Ask a doctor before use if (two bulleted items removed; child has asthma and child has problems and serious side effects etc)

    ■ stomach bleeding warning applies to your child

    ■ child has a history of stomach problems, such as heartburn

    ■ 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, or kidney disease

    ■ child is taking a diuretic

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  • ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

    ■ under a doctor’s care for any serious condition

    ■ taking any other drug

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  • 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

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  • STOP USE AND ASK A DOCTOR IF

    ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

    ■ 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

    ■ 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

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  • 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).

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  • DIRECTIONS

    this product does not contain directions or complete warnings for adult use

    do not give more than directed

    ■ shake well before using

    ■ find right dose on chart below. If possible, use weight to dose; otherwise use age.

    ■ measure with the dosing device provided. Do not use with any other device.

    ■ dispense liquid slowly into the child’s mouth, toward the inner cheek

    ■ if needed, repeat dose every 6 to 8 hours

    ■ do not use more than 4 times a day

    Dosing Chart
    Weight (lb) Age (mos) Dose (mL
    under 6 mos ask a doctor
    12 to 17 lbs 6 to 11 mos 1.25 mL
    18 to 23 lbs 12 to 23 mos 1.875 mL

    Other information

    ■ store between 20 to 25˚C (68 to 77˚F)

    ■ do not use if plastic bottle wrap imprinted “sealed for your protection” is broken or missing

    ■ see bottom panel for lot number and expiration date

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  • INACTIVE INGREDIENTS

    carboxymethylcellulose sodium, citric acid anhydrous, glycerin, microcrystalline cellulose, natural and artificial berry fruit punch type flavor, polysorbate 80, purified water, sodium benzoate, sorbitol solution, sucrose, and xanthan gum.

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  • QUESTIONS

    Questions or Comments?

    call 1-732-940-0358 Monday through Friday 9AM to 5PM EST.

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 27808-007-01

    (15 mL)

    7e1cdb78-figure-01

    27808-007-02

    (30 mL)

    7e1cdb78-figure-02
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  • INGREDIENTS AND APPEARANCE
    CONCENTRATED IBUPROFEN 
    concentrated ibuprofen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:27808-007
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (IBUPROFEN) IBUPROFEN 50 mg  in 1.25 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ANHYDROUS CITRIC ACID  
    SODIUM BENZOATE  
    SORBITOL  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    GLYCERIN  
    XANTHAN GUM  
    POLYSORBATE 80  
    SUCROSE  
    Product Characteristics
    Color WHITE (white to off-white) Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:27808-007-01 15 mL in 1 BOTTLE, PLASTIC
    2 NDC:27808-007-02 30 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079058 11/06/2012
    Labeler - Tris Phrama Inc (947472119)
    Registrant - Tris Pharma Inc (947472119)
    Establishment
    Name Address ID/FEI Business Operations
    Tris Pharma Inc 947472119 MANUFACTURE(27808-007)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharma Solutions Limited 349157623 API MANUFACTURE(27808-007)
    Establishment
    Name Address ID/FEI Business Operations
    Whitehouse Analytical Laboratories  LLC 138628008 ANALYSIS(27808-007)
    Establishment
    Name Address ID/FEI Business Operations
    Perritt Laboratories Inc. 077106284 ANALYSIS(27808-007)
    Establishment
    Name Address ID/FEI Business Operations
    Particle Technology Labs Ltd. 808076947 ANALYSIS(27808-007)
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