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Infants Ibuprofen
Ibuprofen · Suspension
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ibuprofen | 50 mg/1.25mL | 310965 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 079058-001 | IBUPROFEN | SUSPENSION/DROPS | IBUPROFEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 4 | Labeling | Approved | May 10, 2017 | Standard |
| Supplement | 3 | Labeling | Approved | May 10, 2017 | Standard |
| Supplement | 2 | Labeling | Approved | May 10, 2017 | Standard |
| Original application | 1 | Approved | August 31, 2009 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260825). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections 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 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 carton is opened or seal under cap is broken or missing
Warnings
openFDA Drug LabelingWarnings 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 the child has ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if 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 Ask a 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 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 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Do Not Use
openFDA Drug LabelingDo not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if 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
Stop Use
openFDA Drug LabelingStop 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 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
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each 1.25 mL) Ibuprofen USP 50 mg (NSAID) * * nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 58602-227-04 | 58602-227 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLE | April 8, 2024 |
| 58602-227-07 | 58602-227 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-227-07) / 30 mL in 1 BOTTLE | April 8, 2024 |
| 0363-5100-01 | 0363-5100 | Walgreens | 1 BOTTLE in 1 CARTON (0363-5100-01) / 30 mL in 1 BOTTLE | December 4, 2020 |
| 58602-227 | 58602-227 | Aurohealth LLC | — | April 8, 2024 |
| 0363-5100 | 0363-5100 | Walgreens | — | December 4, 2020 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.