Ibuprofen is a nonsteroidal anti-inflammatory drug sold in the U.S. under 17 brand and generic names, for juvenile arthritis, rheumatoid arthritis and bursitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Caldolor (application NDA022348). Other ibuprofen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2.1 ) CALDOLOR Injection vials must be diluted before administration. ( 2.1 ) CALDOLOR Injection bags are ready to use. ( 2.1 ) Adult Pain: 400 mg to 800 mg intravenously over 30 minutes every 6 hours as necessary. ( 2.2 ) Adult Fever: 400 mg intravenously over 30 minutes, followed by 400 mg every 4 to 6 hours or 100-200 mg every 4 hours as necessary. ( 2.2 ) Pediatric (pain and fever) ages 12 to 17 years of age: 400 mg intravenously over 10 minutes every 4 to 6 hours as necessary. ( 2.3 ) Pediatric (pain and fever) aged 6 months to less than 12 years of age: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 400 mg every 4 to 6 hours as necessary. ( 2.3 ) Pediatric (pain and fever) aged 3 months to less than 6 months: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 100 mg. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions ( 5 ) ]. After observing the response to initial therapy with CALDOLOR, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose in adults. Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total…
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.1 )] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.11 ) ] The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%). The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (≥2%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Population…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Over-the-counter | Tablet | Generic | $0 | View → | |
| 2 | 72/100 | Over-the-counter | Capsule | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AI;II | 250 mg / 125 mg | yellow | capsule | — |
| T;II | 250 mg / 125 mg | yellow | oval | — |
| I;I | 250 mg / 125 mg | yellow | oval | — |
| Advil;Cold;Sinus | 200 mg / 30 mg | brown | oval | — |
| 423 | 200 mg / 30 mg | brown | oval | — |
| 423 | 200 mg / 30 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
STRIDES PHARMA INC · Mar 2, 2026
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Acetaminophen and Ibuprofen (NSAID) Tablets
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
IBU (ibuprofen) 600 mg tablets
Failed Tablet/Capsule Specifications
Dr. Reddy's Laboratories, Inc. · Oct 29, 2024
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Direct Rx · Aug 9, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
CALDOLOR is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] Known hypersensitivity to ibuprofen or any component of the drug product ( 4 ) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )
See Table 3 for clinically significant drug interactions with ibuprofen. Table 3: Clinically Significant Drug Interactions with Ibuprofen Drugs That Interfere with Hemostasis Clinical Impact: Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin released by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of CALDOLOR with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.11 ) ]. Aspirin Clinical Impact: Pharmacodynamic (PD) studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric-coated low-dose aspirin. The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if…
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| 3 | 72/100 | Over-the-counter | Capsule | Generic | $0 | View → |
| 4 | 72/100 | Prescription | Suspension | Generic | $0 | View → |
| 5 | 72/100 | Over-the-counter | Tablet | Generic | $0 | View → |
| 6 | 70/100 | Over-the-counter | Capsule | Generic | $0 | View → |
| 7 | Not yet rated | Prescription | Injectable | Generic | $0 | View → |
| 8 | Not yet rated | Prescription | Suspension | Generic | $0 | View → |
| 9 | Not yet rated | Prescription | Tablet | Generic | $0 | View → |
| 10 | Not yet rated | Prescription | Capsule | Generic | $0 | View → |
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| 423 | 200 mg / 30 mg | brown | oval | — |
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| I2 | 200 mg | brown | round | — |
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| I;7 | 600 mg | white | oval | — |
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| 777 | 800 mg / 26.6 mg | white | capsule | — |
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| P366 | 800 mg / 26.6 mg | blue | oval | — |
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| IF826 | 800 mg / 26.6 mg | blue | oval | — |
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