Indications and uses
Temporarily relieves minor aches and pains due to: headache the common cold toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever
Temporarily relieves minor aches and pains due to: headache the common cold toothache muscular aches backache minor pain of arthritis menstrual cramps temporarily reduces fever
do not take more than directed the smallest effective dose should be used do not take longer than 10 days unless directed by a doctor (see warnings) adults and children 12 years of age and older: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years; ask a ...
Ibuprofen USP, 200 mg (NSAID*)
* nonsteroidal anti-inflammatory drug
Pain Reliever / Fever Reducer
Temporarily relieves minor aches and pains due to:
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.
This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause stomach bleeding. The chance is higher if you:
If pregnant or breast - feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other information
acacia, calcium carbonate, carnauba wax, confectioner's sugar,crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicon dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax
LABEL TEXT
NDC 63739-134-01
UD 750 Tablets (25X30)
Mfg. By: Ohm Laboratories, Inc. 14 Terminal Road New Brunswick, NJ 08901
Dist. By: McKesson Packaging 7101 Weddington Rd Concord, NC 28027
LS-134-01-M08-01-A-R2
FOR INSTITUTIONAL USE ONLY See window at back of box for expiration date and lot number.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63739-134-01 | 2021-07-16 | C162847 | 48780-1 | 9d75b9d0-e05f-f424-e053-dadaa90a57ce | Drug Facts |
| 63739-134-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e05f-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-134-01 | EA - Each | 63739-134 | d8c6cbb0-2da8-4131-ae63-01fc9fe4f1b6 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63739-134 | 63739-134-01 |
| 51660-420 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, EXTENDED RELEASE / ORAL | 1.49 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / TOPICAL | 5148 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 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 |
|---|---|---|---|---|---|---|---|
| A071163-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 |
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 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071163-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1986-07-15 | 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 |
|---|---|---|---|---|---|---|
| c74237fc-6e91-f425-e053-2995a90a08a1 | 3d055404-f915-40a4-8f8f-7bc72ee2ce02 | 2021-07-16 | Warnings | 3d055404-f915-40a4-8f8f-7bc72ee2ce02 |
Adverse event summaries are temporarily unavailable. Other product information remains available.