611R Leader Cardinal 70000-0597 Ibuprofen Tablets USP 200 mg
- Manufacturer
- CARDINAL HEALTH | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2022-05-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:41
Label at a glance#
ProductIbuprofen
Active ingredientIBUPROFEN
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
• temporarily relieves minor aches and pains due to:
o headache
o muscular aches
o minor pain of arthritis
o toothache
o backache
o the common cold
o menstrual cramps
• temporarily reduces fever
WARNINGS SECTION
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives
• facial swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters
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 you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
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.
OTC - DO NOT USE SECTION
Do not use
• if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
• right before or after heart surgery
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
• you have problems or serious side effects from taking pain relievers or fever reducers
• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor's care for any serious condition
• taking any other drug
OTC - WHEN USING SECTION
When using this product
• take with food or milk if stomach upset occurs
OTC - STOP USE SECTION
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
you have symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
Directions
• do not take more than directed
• the smallest effective dose should be used
| adults and children 12 years 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 doctor |
OTHER SAFETY INFORMATION
Other information
• store at 20-25ºC (68-77ºF)
INACTIVE INGREDIENT SECTION
Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0597-1 | Ibuprofen | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 70000-0597-1 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 70000-0597-2 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 70000-0597-2 | Ibuprofen | 1 in 1 CARTON | TABLET | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0597 | IBUPROFEN TABLET [CARDINAL HEALTH] | 1 | Current NDC, Legacy NDC, 4 package rows | 20220525_dfbbde4f-633d-6d57-e053-2a95a90ad82f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0597-1 | EA - Each | 70000-0597 | 90d27ecc-59fd-40c1-8b9e-661c362f6fe4 | 1 | 2022-11-07 |
| 70000-0597-2 | EA - Each | 70000-0597 | 387ca778-9bf3-4dcc-8849-31a22971b0de | 1 | 2022-11-07 |
Products#
Every source-derived product name is available through these pages.
- Ibuprofen
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- TITANIUM DIOXIDE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- STARCH, CORN
- TALC
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0597 | 70000-0597-2, 70000-0597-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091237-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 |
Observed Orange Book product history#
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 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091237-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-08 | f41ea6bd6efb… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | CARDINAL HEALTH | dfbbde4f-633d-6d57-e053-2a95a90ad82f | 2022-05-24 | Warnings | 70000-0597-2 70000-0597-1 70000-0597 70000059702 70000059701 dfbbde4f-633e-6d57-e053-2a95a90ad82f dfbbde4f-633d-6d57-e053-2a95a90ad82f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.