Indications and uses
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
• this product does not contain directions or complete warnings for adult use • do not give more than directed • find right dose on chart below. If possible, use weight to dose; otherwise use age. • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day Dosing Chart Weight (lb) Age (yr) Tablets under 24 under 2 ask a doctor 24-35 2-3 1 36-47 4-5 1 ½ 48-59 6-8 2 60-71 9-10 2 ½ 72-95 11 3
• phenylketonurics: contains phenylalanine 6 mg per tablet • store between 20-25 ° C (68-77 ° F) • do not use if printed seal under cap is broken or missing
Ibuprofen 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Dosing Chart | ||
Weight (lb) | Age (yr) | Tablets |
under 24 | under 2 | ask a doctor |
24-35 | 2-3 | 1 |
36-47 | 4-5 | 1 ½ |
48-59 | 6-8 | 2 |
60-71 | 9-10 | 2 ½ |
72-95 | 11 | 3 |
acesulfame potassium, ammonium glycyrrhizin, aspartame, carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, mannitol, natural and artificial flavors, silicon dioxide, sodium lauryl sulfate, soybean oil, succinic acid
1-800-719-9260
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 1 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 41520-600 | 41520-600-62 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| AMMONIUM GLYCYRRHIZATE | 3VRD35U26C | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SOYBEAN OIL | 241ATL177A | IACT |
| SUCCINIC ACID | AB6MNQ6J6L | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / SUBLINGUAL | 495 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPRAY / TOPICAL | 7 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE / ORAL | 46 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION / ORAL | 705 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED / ORAL | 2309 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, EFFERVESCENT / ORAL | 1.5 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SOLUTION / ORAL | 117 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER, FOR SUSPENSION / ORAL | 64 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE / ORAL | 1562 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAMUSCULAR | 106.6 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | FILM, SOLUBLE / ORAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15400 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | AEROSOL, FOAM / TOPICAL | 50 %w/w | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | INJECTION / INTRAMUSCULAR | ADJ PH | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION, EXTENDED RELEASE / ORAL | 0.08 mg/1ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, COATED PELLETS / ORAL | 1 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET / SUBLINGUAL | 8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | SOLUTION / ORAL | 0.01 mg/1ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076359-001 | IBUPROFEN | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | ||
| A076359-002 | IBUPROFEN | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | 74a2ff9319b5… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f13b4d69-fc00-4bf6-9198-014b756f054a | 368e6d1b-8521-4ca6-9151-e69ea7660b04 | 2021-11-12 | Warnings | 368e6d1b-8521-4ca6-9151-e69ea7660b04 |
Adverse event summaries are temporarily unavailable. Other product information remains available.