Indications and uses
_ temporarily relieves minor aches and pains due to: _ backache _ muscular aches _ minor pain of arthritis _ headache _ menstrual cramps _ toothache _ the common cold _ temporarily reduces fever Drug Facts (continued)
Dye Free Ibuprofen
- Manufacturer
- Breeden Brothers, LLC
- Effective date
- 2017-02-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:53:36
Label at a glance#
ProductDye Free Ibuprofen
Active ingredientIBUPROFEN
Label structure10 sections
Dosage and administration
_ do not take more than directed _ the smallest effective dose should be used _ adults and children 12 years and over: 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 Drug Facts (continued)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each white tablet)
Ibuprofen USP, 200 mg (NSAID)*
Purpose
Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
Uses
_ temporarily relieves minor aches and pains due to:
_ backache _ muscular aches _ minor pain of arthritis
_ headache _ menstrual cramps
_ toothache _ the common cold
_ temporarily reduces fever
Drug Facts (continued)
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.
Drug Facts (continued)
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 any other pain reliever/fever reducer
_ right before or after heart surgery
Ask a doctor before use if
_ 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
_ you have problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
_ under a doctor's care for any serious condition
_ taking any other drug
Drug Facts (continued)
_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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 _ slurred speech
_ leg swelling _ trouble breathing
_ weakness in one part or side of body
_ pain gets worse or lasts more than 10 days
_ fever gets worse or lasts more than 3 days
_ any new symptoms appear
_ redness or swelling is present in the painful area
Drug Facts (continued)
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.
Directions
_ do not take more than directed
_ the smallest effective dose should be used
_ adults and children 12 years and over: 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
Drug Facts (continued)
Other information
_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
_ store between 20°-25°C (68°-77°F)
_ avoid excessive heat 40°C (104°F)
_ use by expiration date on package
Inactive ingredients
corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
Questions or comments?
1-800-901-2420
Dist. by Breeden Brothers, LLC
Nashville, TN 37219
PRINCIPAL DISPLAY PANEL
b+b
better by giving
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 |
|---|---|---|---|---|---|---|
| 70729-002-24 | Dye Free Ibuprofen | 24 in 1 BOTTLE | TABLET | 24 | 1 | |
| 70729-002-50 | Dye Free Ibuprofen | 50 in 1 BOTTLE | TABLET | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Dye Free Ibuprofen
- Ibuprofen
- HYPROMELLOSE, UNSPECIFIED
- TRIACETIN
- MAGNESIUM STEARATE
- STEARIC ACID
- STARCH, CORN
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- ANHYDROUS LACTOSE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70729-002 | 70729-002-24, 70729-002-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|---|
| A075139-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 |
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 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075139-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 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 |
|---|---|---|---|---|---|---|
| Dye Free Ibuprofen | IBUPROFEN | Breeden Brothers, LLC | ba106f6f-2c6b-4c98-a10e-d27622b08b25 | 2017-02-15 | Warnings | 70729-002-50 70729-002-24 70729-002 70729000224 70729000250 e7bbd188-5e3e-4f1c-96d8-53f6de4b3120 ba106f6f-2c6b-4c98-a10e-d27622b08b25 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.