CONCENTRATED IBUPROFEN - ibuprofen suspension 
Tris Phrama Inc

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Infants’ Concentrated Ibuprofen Oral Suspension, USP

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 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.

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

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

ASK 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

■ 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.

■ 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

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

■ 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

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 or Comments?

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27808-007-01

(15 mL)

7e1cdb78-figure-01

27808-007-02

(30 mL)

7e1cdb78-figure-02
CONCENTRATED IBUPROFEN 
concentrated ibuprofen suspension
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27808-007
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg  in 1.25 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SUCROSE (UNII: C151H8M554)  
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)

Revised: 11/2012
Document Id: 7e1cdb78-1596-4349-b87c-bd27dac70e78
Set id: 7f9d09db-170c-474c-b378-0bf4d499d769
Version: 2
Effective Time: 20121101
 
Tris Phrama Inc