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
• chew or crush tablets completely before swallowing • 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...
• 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
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-521-62 | rexall ibuprofen | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 4 | |
| 55910-521-62 | rexall ibuprofen | 24 in 1 BOTTLE | TABLET, CHEWABLE | 24 | 4 |
| 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 |
|---|---|
| 55910-521 | 55910-521-62 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | SOLUTION / ORAL | 0.01 mg/1ml | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, SUGAR COATED / ORAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, CHEWABLE / ORAL | 6 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | CAPSULE / ORAL | 390 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | CONCENTRATE / ORAL | 60 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | CAPSULE / ORAL | 1318 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | TABLET / ORAL | 125.3 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | TABLET, EXTENDED RELEASE / ORAL | 648 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| ACESULFAME POTASSIUM | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, CHEWABLE / ORAL | 15 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | TABLET, EXTENDED RELEASE / ORAL | 648 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | TABLET / ORAL | 125.3 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | SOLUTION / ORAL | 0.01 mg/1ml | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | CAPSULE / ORAL | 390 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | CONCENTRATE / ORAL | 60 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| SUCCINIC ACID | SUCCINIC ACID | AB6MNQ6J6L | POWDER, FOR SUSPENSION / ORAL | 5 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, DELAYED RELEASE / ORAL | 230 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 |
|---|---|---|---|---|---|---|
| rexall ibuprofen | IBUPROFEN | Dolgencorp, LLC | 869185d5-9f34-4d38-9551-dd0b4fc8557d | 2021-09-09 | Warnings | 55910-521-62 55910-521 55910052162 b212f505-a545-4e5a-84d8-35b96ad4f463 869185d5-9f34-4d38-9551-dd0b4fc8557d |
Adverse event summaries are temporarily unavailable. Other product information remains available.