Indications and uses
• temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o minor pain of arthritis
• temporarily relieves minor aches and pains due to: o headache o toothache o backache o menstrual cramps o muscular aches o 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 20-25ºC (68-77ºF) • 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:
o headache
o toothache
o backache
o menstrual cramps
o muscular aches
o minor pain of arthritis
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.
• 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:
o feel faint
o vomit blood
o have bloody or black stools
o have stomach pain that does not get better
• you have symptoms of heart problems or stroke:
o chest pain
o trouble breathing
o weakness in one part or side of body
o slurred speech
o 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.
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 20-25ºC (68-77ºF)
• avoid excessive heat above 40°C (104°F)
colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
Distributed by:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Made in India
NDC 25000-080-72
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
18 count carton label

NDC 25000-080-72
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
18 count bottle label

NDC 25000-080-07
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
90 count carton label

NDC 25000-080-07
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
90 count bottle label
NDC 25000-080-74
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
288 count bottle label

| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0325000080075 | GTIN-13: 0325000080075 EAN-13: 0325000080075 GTIN-12: 325000080075 UPC-A: 325000080075 GTIN storage (14 digits): 00325000080075 | aceta-ibu-90s-ifc-label.jpg |
| Barcode | EAN-13 | 0325000080723 | GTIN-13: 0325000080723 EAN-13: 0325000080723 GTIN-12: 325000080723 UPC-A: 325000080723 GTIN storage (14 digits): 00325000080723 | aceta-ibu-18s-ifc-label.jpg |
| Barcode | EAN-13 | 0325000080747 | GTIN-13: 0325000080747 EAN-13: 0325000080747 GTIN-12: 325000080747 UPC-A: 325000080747 GTIN storage (14 digits): 00325000080747 | aceta-ibu-288s-bottle-label.jpg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25000-080-07 | Acetaminophen 250 mg and Ibuprofen 125 mg | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 6 | |
| 25000-080-07 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 25000-080-72 | Acetaminophen 250 mg and Ibuprofen 125 mg | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | 6 | |
| 25000-080-72 | Acetaminophen 250 mg and Ibuprofen 125 mg | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 6 | |
| 25000-080-74 | Acetaminophen 250 mg and Ibuprofen 125 mg | 288 in 1 BOTTLE | TABLET, FILM COATED | 288 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 25000-080 | 25000-080-72, 25000-080-07, 25000-080-74 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| GLYCERYL DIBEHENATE | R8WTH25YS2 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen 250 mg and Ibuprofen 125 mg | ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETS | MARKSANS PHARMA LIMITED | 46121a30-1361-4f2b-9f3f-3cedabd66c33 | 2025-12-12 | Warnings | 25000-080-07 25000-080-72 25000-080-74 25000-080 25000008072 25000008074 25000008007 38a01bed-7a8b-4aed-97c1-cc1545f76f79 46121a30-1361-4f2b-9f3f-3cedabd66c33 |
Adverse event summaries are temporarily unavailable. Other product information remains available.