Ibuprofen Tablets, USP 200mg (NSAID)
- Manufacturer
- Apotheca, Inc
- Effective date
- 2014-03-03
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:18:19
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug
PURPOSE
Pain reliever / fever reducer
Use(s)
temporarily relieves minor aches and pain due to :
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever
WARNINGS
Allergy alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:
- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
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 bad stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drug containing prescription NSAID (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- the 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 DOCTOR/PHARMACIST
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 diuretics
- reached age 60 or older
Ask a doctor or pharmacist before use if you are
- taking any other drugs containg an NSAID (prescription or nonprescription)
- taking a blood thining (anticoagulant) or steriod drug
- under a doctor’s care for any serious condition
- taking aspirin for heart attacks or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask doctor if
- you feel faint, vomit blood, or have bloody or black stools
- 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 painful area
- any new symptoms appear
PREGNACNCY 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 a 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 PoisonControlCenter right away. (1-800-222-1222)
INACTIVE INGREDIENTS
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.
QUESTIONS
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a docter
adults and children 12 years and older |
|
Children under 12 years |
|
Other information
store between 20-25 0c (68-77 0 F).
- do not use if seal under bottle cap imprinted with” SEALED for YOUR PROTECTION” is broken or missing
PRINCIPAL DISPLAY PANEL
Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY11755, USA
Manufactured by:
Marksans Pharma Ltd.
Verna, Goa-403722, India
Repackaged and Distributed by:
Apotheca, Inc.
Phoenix, AZ 85006
Repackaged and Distributed for:
RejuviLife
Phoenix, AZ 85015
NDC 12634-518-74
IBUPROFEN
MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION
BROWN COATED TABLETS
Pain Reliver
Fever Reducer
RejuviLife®
24 TABLETS 200MG
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 12634-518-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2ae1-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP 200mg (NSAID) |
| 12634-518-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2ae1-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP 200mg (NSAID) |
| 12634-518-74 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2ae1-f424-e053-dadaa90a57ce | Ibuprofen Tablets, USP 200mg (NSAID) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-518-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 12634-518-10 | Ibuprofen | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 12634-518-74 | Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Ibuprofen
- COLLOIDAL SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FERRIC OXIDE RED
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 12634-518 | 12634-518-74, 12634-518-01, 12634-518-10 |
| 25000-114 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| COLLOIDAL SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 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 |
|---|---|---|---|---|---|---|---|
| A091239-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091239-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-02-01 | 3a93d1ddd44b… |
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 | MARKSANS PHARMA LIMITED | 3c8df1e5-61bc-4e70-b6b9-8973986ad589 | 2021-12-21 | Warnings | 25000-114 |
| 2757f53a-602c-4678-80f5-61c3d9dfd4a3 | 3fd625e4-0d06-4efb-abd1-42281e7a6af0 | 2014-03-03 | Warnings | 2757f53a-602c-4678-80f5-61c3d9dfd4a3 3fd625e4-0d06-4efb-abd1-42281e7a6af0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
