Storage and handling
Other information read all warnings and directions before use. Keep carton. store at 20-25ºC (68-77ºF) avoid excessive heat above 40°C (104°F)
Other information read all warnings and directions before use. Keep carton. store at 20-25ºC (68-77ºF) avoid excessive heat above 40°C (104°F)
Active ingredients (in each caplet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Uses
temporarily relieves minor aches and pains due to:
Warnings
Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• with other drugs containing acetaminophen
• more than 6 caplets in 24 hours, which is the maximum daily amount for this product
• 3 or more alcoholic drinks every day while using this product
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If skin reaction occurs, stop use and seek medical help right away.
NSAID 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.
NSAID 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. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do not use
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• if you have ever had an allergic reaction to acetaminophen or any other pain reliever
• right before or after heart surgery
Ask a doctor before use if
• you have liver disease
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers
• 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
• under a doctor’s care for any serious condition
• taking aspirin for heart attack 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
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
you have symptoms of heart problems or stroke:
pain gets worse or lasts more than 10 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 at 20 weeks or later in 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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
adults and children 12 years and over |
|
| children under 12 years |
|
Other information
Inactive ingredients colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.
Questions or comments? Call 1-800-910-6874
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| 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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-924-75 | Dual Action Pain Relief | 72 in 1 BOTTLE | TABLET | 72 | 3 | |
| 11673-924-75 | Dual Action Pain Relief | 1 in 1 CARTON | TABLET | 1 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11673-924 | 11673-924-75 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERYL DIBEHENATE | R8WTH25YS2 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POVIDONE | FZ989GH94E | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A216994-001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 |
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 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | a67488948f0b… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216994-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-10 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Dual Action Pain Relief | ACETAMINOPHEN, IBUPROFEN | TARGET CORPORATION | e680652b-30d8-6009-e053-2995a90abe29 | 2024-09-25 | Warnings | 11673-924-75 11673-924 11673092475 22ecfa46-dbe4-249f-e063-6394a90a70af e680652b-30d8-6009-e053-2995a90abe29 |
Adverse event summaries are temporarily unavailable. Other product information remains available.