Infants Ibuprofen by Actavis Pharma, Inc.
Dosage form: suspension
Ingredients: IBUPROFEN 50mg in 1.25mL
Labeler: Actavis Pharma, Inc.
NDC Code: 45963-125
Ibuprofen 50 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
- 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:
- facial swelling
- asthma (wheezing)
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your 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
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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, kidney disease, or had a stroke
- 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
- 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
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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.
- mL = milliliter
- 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
|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
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.
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Compare to the active ingredient in Concentrated Motrin® Infants’ Drops†
See New Warnings
For Ages 6 Mos. to 23 Mos.
Concentrated Ibuprofen Oral Suspension, USP
50 mg per 1.25 mL
Lasts up to 8 hours
Use only with enclosed syringe
Dye-Free Berry Flavor
½ FL OZ (15 mL)
|Labeler - Actavis Pharma, Inc. (119723554)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.