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
Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug Facts
- Manufacturer
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Effective date
- 2020-02-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:13:51
Label at a glance#
Productibuprofen
Active ingredientIBUPROFEN
Label structure9 sections
Dosage and administration
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
Storage and handling
read all warnings and directions before use store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) see end panel for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
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
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 chances are 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.
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
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
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
When using this product
- take with food or milk if stomach upset occurs
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
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 (1-800-222-1222).
Directions
- do not take more than directed
- the smallest effective dose should be used
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Other information
- read all warnings and directions before use
- store at 20-25°C (68-77°F)
- avoid high humidity and excessive heat above 40°C (104°F)
- see end panel for lot number and expiration date
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
Questions or comments?
1-800-719-9260
Principal Display Panel
NDC: 70934-498-30
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-498-30 | 2023-01-25 | C162847 | 48780-1 | d6a99b39-b07e-a426-e053-dadaa90af4c2 | Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug Facts |
| 70934-498-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-b07e-a426-e053-dadaa90af4c2 | Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7912-24 | EA - Each | 0904-7912 | ec60efa7-0c06-43e7-8911-c8b02f7d2f71 | 1 | 2013-12-02 |
| 0904-7912-51 | EA - Each | 0904-7912 | 8bdfcdc9-7024-457f-aaa6-c2919ddd129c | 1 | 2012-07-24 |
| 0904-7912-59 | EA - Each | 0904-7912 | 9e0a1d87-95f0-4f7d-b444-64dd518bb4eb | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- ibuprofen
- SILICON DIOXIDE
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- HYPROMELLOSES
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL
- POLYSORBATE 80
- STEARIC ACID
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70934-498 | 70934-498-30 |
| 0904-7912 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A072096-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 |
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 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 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 | Major Pharmaceuticals | 03993008-7bd2-465f-b5a9-1cbc3c1fff02 | 2025-06-16 | Warnings | 0904-7912 |
| f19de6f9-832a-d383-e053-2a95a90a4bea | a8b0ade2-69bf-2cb5-e053-2a95a90a13e3 | 2023-01-06 | Warnings | a8b0ade2-69bf-2cb5-e053-2a95a90a13e3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.