CONCENTRATED IBUPROFEN- concentrated ibuprofen suspension
Tris Pharma Inc
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Read all product information before using. Keep this box for important information. This product is intended for use in children ages 6 months to 23 months of age.
temporarily:
■ reduces fever
■ relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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.
■ if the child has ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
■ 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, or kidney disease
■ child has asthma
■ child is taking a diuretic
■ under a doctor’s care for any serious condition
■ taking any other drug
■ 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
■ 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
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
■ 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 date
CONCENTRATED IBUPROFEN
concentrated ibuprofen suspension |
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Labeler - Tris Pharma Inc (947472119) |
Registrant - Tris Pharma Inc (947472119) |