Indications and uses
■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
■ temporarily relieves minor aches and pains due to: ■ headache ■ toothache ■ backache ■ menstrual cramps ■ muscular aches ■ minor pain of arthritis
■ do not take more than directed adults and children 12 years and over ■ take 2 caplets every 8 hours while symptoms persist children under 12 years ■ ask a doctor ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
■ read all warnings and directions before use. Keep carton. ■ store at 20 to 25°C (68 to 77°F) ■ avoid excessive heat above 40°C (104°F)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID**)
**nonsteroidal anti-inflammatory drug
Pain reliever
Pain reliever
■ temporarily relieves minor aches and pains due to:
■ headache
■ toothache
■ backache
■ menstrual cramps
■ muscular aches
■ minor pain of arthritis
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
may cause severe skin reactions. Symptoms may include:
■ skin reddening
■ blisters
■ rash
If skin reaction occurs, stop use and seek medical help right away.
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.
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
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.
■ 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
■ 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
■ 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
■ Take with food or milk if stomach upset occurs
■ 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
■ trouble breathing
■ weakness in one part or side of body
■ slurred speech
■ leg swelling
■ pain gets worse or lasts more than 10 days
■ redness or swelling is present in the painful area
■ any new symptoms appear
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.
■ do not take more than directed
adults and children 12 years and over
■ take 2 caplets every 8 hours while symptoms persist
children under 12 years
■ ask a doctor
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
■ read all warnings and directions before use. Keep carton.
■ store at 20 to 25°C (68 to 77°F)
■ avoid excessive heat above 40°C (104°F)
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
| 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 |
|---|---|---|---|---|---|---|
| 70000-0622-1 | Acetaminophen and Ibuprofen | 18 in 1 BOTTLE | TABLET | 18 | 10 | |
| 70000-0622-2 | Acetaminophen and Ibuprofen | 36 in 1 BOTTLE | TABLET | 36 | 10 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0622-1 | EA - Each | 70000-0622 | 68659a79-f53e-4eb4-a9d6-92b4314c7ac5 | 1 | 2024-03-12 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0622 | 70000-0622-1, 70000-0622-2 |
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 |
|---|---|---|---|---|---|---|---|
| A216592-001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 |
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 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216592-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2023-07-13 | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen and Ibuprofen | ACETAMINOPHEN AND IBUPROFEN | LEADER/ Cardinal Health 110, Inc. | f1d69088-4d52-cbb5-e053-2995a90a3ec8 | 2025-12-19 | Warnings | 70000-0622-1 70000-0622-2 70000-0622 70000062202 70000062201 4652fd1e-ed26-2a97-e063-6394a90a7e1a f1d69088-4d52-cbb5-e053-2995a90a3ec8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.