Active ingredient

Active ingredient (in each 1.25 mL)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses temporarily:

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

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 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 an NSAID (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.

Do not use

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

Ask a doctor before use if the child has

problems or serious side effects from taking pain relievers or fever reducers
stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
not been drinking fluids
lost a lot of fluid due to vomiting or diarrhea
high blood pressure
heart or kidney disease
asthma
taken a diuretic

Ask a doctor or pharmacist before use if the child is

taking any other drug containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
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
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

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
the child feels faint, vomits blood or has bloody or black stools. There are signs of stomach bleeding.
stomach pain or upset gets worse or lasts
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 (1-800-222-1222) right away.

Directions

this product does not contain directions or complete warnings for adult use
do not give more than directed
do not give longer than 10 days, unless directed by a doctor (see Warnings)
shake well before using
find right dose on chart. 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

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.

Questions

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CONCETRATED IBUPROFEN
concentrated ibuprofen suspension

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	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

Product Characteristics
Color	WHITE (white to off-white)	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	27808-007-01	15 mL In 1 BOTTLE, PLASTIC	None
2	27808-007-02	30 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079058	08/31/2009

Labeler - Tris Phrama, Inc. (947472119)

Registrant - Tris Pharma, Inc. (947472119)

Establishment
Name	Address	ID/FEI	Operations
Tris Pharma, Inc		947472119	MANUFACTURE, ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Shasun Chemicals & Drugs Ltd.		650064850	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Whitehouse Analytical Laboratories, LLC		138628008	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Perritt Laboratories Inc.		111111111	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Particle Technology Labs, Ltd.		808076947	ANALYSIS

Revised: 08/2009Tris Phrama, Inc.