Ibuprofen Tablets, USP (NSAID) Pain Reliever/ Fever Reducer
- Manufacturer
- NCS HealthCare of KY, Inc dba Vangard Labs
- Effective date
- 2012-02-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:49:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
*Compared to the active ingredient of Advil®
Drug Facts
ACTIVE INGREDIENT
(in each Tablet)
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Inactive Ingredients
Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide.
PURPOSE
Pain reliever/fever reducer
Indications & Usage
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- minor pain or 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 NSAID (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
Do not use
- if you have ever had an allergic reaction to 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
- stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
- ulcers
- bleeding problems
- high blood pressure
- heart or kidney disease
- taken a diuretic
- reached age 60 or older
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
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- 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
- long term continuous use ay increase the risk of heart attack or stroke
Stop use and ask a doctor if
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
- 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
- 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 (1-800-222-1222) right away.
Dosage & Administration
- 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 and older |
|
| Children under 12 years |
|
Other information
- store at 20 – 25°C (68 – 77°F).
- Read all warnings and directions before use
Questions or Comments?
Call 1-877-835-5472
Monday though Friday 9AM – 5PM EST.
SPL UNCLASSIFIED SECTION
Distributed by:
Amneal Pharmaceuticals
Glasgow, KY 42141
SPL UNCLASSIFIED SECTION
*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®
Rev. 10-2008
PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0615-3527-39 | 2021-06-28 | C162847 | 48780-1 | 97449f38-b8e8-f6ea-e053-dbdaa90aa703 | Ibuprofen Tablets, USP (NSAID) Pain Reliever/ Fever Reducer |
| 0615-3527-39 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b8e8-f6ea-e053-dbdaa90aa703 | Ibuprofen Tablets, USP (NSAID) Pain Reliever/ Fever Reducer |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53746-140-01 | EA - Each | 53746-140 | 9b59909e-f012-4650-b0bb-48b247569696 | 1 | 2013-02-11 |
| 53746-140-10 | EA - Each | 53746-140 | ec68f427-dec6-4174-929c-cfc07f475edc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 4 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 4 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 4 |
Products#
Every source-derived product name is available through these pages.
- Ibuprofen
- ANHYDROUS LACTOSE
- CARNAUBA WAX
- SILICON DIOXIDE
- HYPROMELLOSES
- FERRIC OXIDE RED
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POLYDEXTROSE
- POLYETHYLENE GLYCOLS
- POVIDONE
- SODIUM LAURYL SULFATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0615-3527 | 0615-3527-39 |
| 53746-140 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
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, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / ORAL | 233 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg |
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 |
|---|---|---|---|---|---|---|---|
| A071333-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 |
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 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 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 Pain Releiver/ Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | ee241be0-35f8-4789-a71f-98de31d6a590 | 2023-12-31 | Warnings | 53746-140 |
| 915618ec-ed9f-4094-a144-dfae11a60690 | 1b2ab0e2-ed21-4df8-bed2-55728a505c7d | 2012-02-24 | Warnings | 1b2ab0e2-ed21-4df8-bed2-55728a505c7d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
