Label: CONCENTRATED IBUPROFEN - ibuprofen suspension
- 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.
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- ACTIVE INGREDIENT (in each 1.25 mL)
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drugClose
Pain reliever/Fever reducerClose
■ reduces fever
■ relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothachesClose
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.Close
- DO NOT USE
■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgeryClose
- 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 diureticClose
- ASK DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
■ under a doctor’s care for any serious condition
■ taking any other drugClose
- 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 directedClose
- 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 appearClose
- 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).Close
■ 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
■ 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 dateClose
- 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.Close
Questions or Comments?
call 1-732-940-0358 Monday through Friday 9AM to 5PM EST.Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
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)