Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
Ibuprofen USP, 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain Reliever/ fever Reducer
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 an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide.
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Ibuprofen Tablets USP, 200 mg
Pain Reliever/ Fever Reducer (NSAID)
Coated Caplets**
**(Capsule-shaped Tablets)
DO NOT USE IF TAMPER- EVIDENT SEAL UNDER BOTTLE CAP IS IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
Manufactured by:
Avema Pharma Solutions
10400 NW 29th terrace
Miami, FL 33172
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63548-0186 | 63548-0186-2, 63548-0186-1, 63548-0186-3 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 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 |
|---|---|---|---|---|---|---|---|
| A076460-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 |
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 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| a4cff69f-f461-4b71-bb35-fa685552a556 | 165ae474-fb89-4b72-a1ce-a123963adaaa | 2019-09-03 | Warnings | a4cff69f-f461-4b71-bb35-fa685552a556 165ae474-fb89-4b72-a1ce-a123963adaaa |
Adverse event summaries are temporarily unavailable. Other product information remains available.