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 a caplet every 4 to 6 hours while symptoms persist ■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours , unless directed by a doctor childer under 12 years ■ ask a doctor
Drug Facts
(in each tablet)
Ibuprofen 200 mg (NSAID)*
Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
■ 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
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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgery
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, or kidney disease
■ you have asthma
■ you are taking a diuretic
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
this product
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling id present in the painful area
■ any new symptoms appear
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 .
In case of overdose ,get medical help or contact a Poison Control Center right away .(1-800-222-1222)
■ do not take more than directed .
■ the smallest effective dose should be used
| adults and children 12 years and older | ■ take a caplet every 4 to 6 hours while symptoms persist
■ if pain or fever dose not respond to 1 tablet, 2 tablets may be used ■ do not exceed 6 tablets in 24 hours , unless directed by a doctor |
| childer under 12 years | ■ ask a doctor |
OTHER INFORMATION
■ store between 20-25ºC (68-77ºF)
■ do not use if foil inner seal is broken or missing
■ see end panel for lot number and expiration date
colloidal silicon dioxide, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maize starch, maltodextrin, pregelatinized starch, povidone k30, sodium starch glycolate, stearicacid, sodium carboxymellose, triacetin, titanium dioxide
Call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST
M.L. 37/RR/AR/2003/F/R
Manufactured By:
Granules India Limited
2nd Floor 3rd Black, My Home hub
Madhapur, Hyderabad – 500 081, India
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62207-365 | 62207-365-24, 62207-365-25, 62207-365-26, 62207-365-27, 62207-365-66, 62207-365-67, 62207-365-80, 62207-365-68, 62207-365-16 |
| 62207-366 | 62207-366-24, 62207-366-25, 62207-366-26, 62207-366-27, 62207-366-66, 62207-366-67, 62207-366-80, 62207-366-68 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A079174-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 |
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 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Granules India Limited | fd01353d-1d1d-42b5-9a03-575052189bf5 | 2024-08-13 | Warnings | 62207-365 62207-366 |
Adverse event summaries are temporarily unavailable. Other product information remains available.