INDICATIONS & USAGE SECTION
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • temporarily reduces fever
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 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.
Warnings:
Allergy Alert: Ibuprofen may cause a severe allergic
reaction which may include:
• hives • shock • facial swelling • asthma (wheezing)
Alcohol Warning: If you consume 3 or more alcoholic
drinks every day, ask your doctor whether you should
take Ibuprofen or other pain relievers/ fever reducers.
Ibuprofen may cause stomach bleeding.
Do not use:
• if you have ever had an allergic reaction to any
other pain reliever/fever reducer
Ask a doctor before use if you have:
• stomach pain
• problems or serious side eects from taking
pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are:
• under a doctor's care for any serious condition
• taking any other drug
• taking any other product that contains Ibuprofen,
or any other pain reliever/fever reducer
When using this product give with food or milk if
stomach upset occurs.
Stop use and ask a doctor if:
• an allergic reaction occurs. Seek medical help right
away • pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• stomach pain or upset gets worse or lasts
• any new symptoms appear • redness or swelling is
present in the painful area
Directions:
• Do not take more than directed.
Adults and children 12 years and older
• Take 1 tablet every 4 to 6 hours while symptoms
• If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.
• The smallest effective dose should be used.
Children under 12 year
• Ask a doctor.
Inactive Ingredients:
carnauba wax, croscarmellose sodium,
hydroxypropyl methylcellulose,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, pregelatinized starch, silicon
dioxide, sodium starch glycolate,
stearic acid and titanium dioxide.
ACTIVE INGREDIENT-IBUPROFEN 200 MG
PAIN RELIEVER/FEVER REDUCER
| 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 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 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 |
|---|---|---|---|---|---|---|
| 69103-2525-5 | Flex-Prin | 2 in 1 PACKET | TABLET | 2 | 3 | |
| 69103-2525-5 | Flex-Prin | 250 in 1 CARTON | TABLET | 250 | 3 | |
| 69103-2525-6 | Flex-Prin | 2 in 1 PACKET | TABLET | 2 | 3 | |
| 69103-2525-6 | Flex-Prin | 100 in 1 CARTON | TABLET | 100 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69103-2525 | FLEX-PRIN (IBUPROFEN) TABLET [PROVISION MEDICAL PRODUCTS] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230107_c01538b0-ca4c-434a-be8f-fe023deb84e1.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69103-2525 | 69103-2525-5, 69103-2525-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| STARCH, PREGELATINIZED CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 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 |
|---|---|---|---|---|---|---|---|
| A079129-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 |
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 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 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 |
|---|---|---|---|---|---|---|
| Flex-Prin | IBUPROFEN | Provision Medical Products | c01538b0-ca4c-434a-be8f-fe023deb84e1 | 2023-01-05 | Warnings | 69103-2525-5 69103-2525-6 69103-2525 69103252505 69103252506 f18ebbe5-cd44-8c27-e053-2a95a90ab79b c01538b0-ca4c-434a-be8f-fe023deb84e1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.