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 the 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 glycerrhizin, 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
1-877-932-7948
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 41163-521-62 | EA - Each | 41163-521 | 7c096b13-e8d2-47c0-96d0-fb15b0d36eea | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 2 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 2 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 41163-521 | 41163-521-62 |
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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / SUBCUTANEOUS | 675 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15400 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FOR SUSPENSION / ORAL | 264 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, DELAYED RELEASE / ORAL | 199 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 113 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION, EXTENDED RELEASE / ORAL | 2464.6 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 99 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, CONCENTRATE / INTRAVENOUS | 220 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | GUM, CHEWING / BUCCAL | 147 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | SOLUTION / ORAL | 400 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / BUCCAL | 5.18 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | POWDER, FOR SUSPENSION / ORAL | 45 mg/5ml | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING / ORAL | 16 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE, EXTENDED RELEASE / ORAL | 166 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAVENOUS | 15200 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | INJECTION / INTRAVENOUS | 38 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE / ORAL | 1328 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076359-001 | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 2004-01-16 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A076359-002 | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | RS | 2004-01-16 | c2088c7a36db… | |
| 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… |
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 |
|---|---|---|---|---|---|---|
| 7350f766-4a66-4125-a1b2-fdd37d7e5aef | e3aac5f2-5626-48c9-aad3-d8bccf893d14 | 2021-11-19 | Warnings | e3aac5f2-5626-48c9-aad3-d8bccf893d14 |
Adverse event summaries are temporarily unavailable. Other product information remains available.