Infants Ibuprofen 50 mg/1.25mL
Ibuprofen · SUSPENSION · Aurohealth LLC
Infants Ibuprofen is a nonsteroidal anti-inflammatory medication available without a prescription that helps reduce fever and relieve pain in infants and young children. This liquid suspension form makes it easy to give to babies who cannot yet swallow pills.
Key Facts
- Brand Name
- Infants Ibuprofen
- Generic Name
- Ibuprofen
- NDC Code (Product)
58602-227- Manufacturer
- Aurohealth LLC
- Strength
- 50 mg/1.25mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213506
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 04/08/2024
Recall History
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Tris Pharma Inc.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Dosage & Administration
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. • 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 6-8 hours • do not use more than 4 times a day Dosing Chart Weight (lbs) Age (mos) Dose (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 mos 1.875 mL
Warnings
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 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. Do not use • if…
Frequently Asked Questions
What is Infants Ibuprofen used for?
Infants Ibuprofen is a nonsteroidal anti-inflammatory medication available without a prescription that helps reduce fever and relieve pain in infants and young children. This liquid suspension form makes it easy to give to babies who cannot yet swallow pills.
Is Infants Ibuprofen a controlled substance?
Infants Ibuprofen is not classified as a controlled substance by the DEA.
What is the generic name for Infants Ibuprofen?
The generic name for Infants Ibuprofen is Ibuprofen. There are 12 other brand versions of Ibuprofen.
What is the NDC code for Infants Ibuprofen 50 mg/1.25mL?
The NDC (National Drug Code) for Infants Ibuprofen 50 mg/1.25mL is 58602-227, listed by Aurohealth LLC.