Indications and uses
Uses • temporarily relieves minor aches and pains due to: • backache • muscular aches • minor pain of arthritis • headache • toothache • menstrual cramps
Uses • temporarily relieves minor aches and pains due to: • backache • muscular aches • minor pain of arthritis • headache • toothache • menstrual cramps
Other information • read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)
Acetaminophen USP, 250 mg
Ibuprofen USP, 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain Reliever
Pain Reliever
Uses
Warnings
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
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:
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:
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.
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
black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, glyceryl dibehenate, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium lauryl sulfate, titanium dioxide
Questions or comments?
call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)
Distributed By:
Dr. Reddy's Laboratories, Inc.
Princeton, NJ 08540
Made in India
Rev: 02/25
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75907-260-14 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-348f-fb37-e063-e6dba90a4e07 | Acetaminophen Ibuprofen (NSAID) Tab 250mg/125mg |
| 75907-260-18 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-348f-fb37-e063-e6dba90a4e07 | Acetaminophen Ibuprofen (NSAID) Tab 250mg/125mg |
| 75907-260-25 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-348f-fb37-e063-e6dba90a4e07 | Acetaminophen Ibuprofen (NSAID) Tab 250mg/125mg |
| 75907-260-55 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-348f-fb37-e063-e6dba90a4e07 | Acetaminophen Ibuprofen (NSAID) Tab 250mg/125mg |
| 75907-260-95 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-348f-fb37-e063-e6dba90a4e07 | Acetaminophen Ibuprofen (NSAID) Tab 250mg/125mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75907-260-14 | Acetaminophen Ibuprofen (NSAID) | 144 in 1 BOTTLE | TABLET, FILM COATED | 144 | 1 | |
| 75907-260-18 | Acetaminophen Ibuprofen (NSAID) | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | 1 | |
| 75907-260-18 | Acetaminophen Ibuprofen (NSAID) | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 75907-260-25 | Acetaminophen Ibuprofen (NSAID) | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 1 | |
| 75907-260-25 | Acetaminophen Ibuprofen (NSAID) | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 75907-260-55 | Acetaminophen Ibuprofen (NSAID) | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 1 | |
| 75907-260-95 | Acetaminophen Ibuprofen (NSAID) | 250 in 1 BOTTLE | TABLET, FILM COATED | 250 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75907-260 | 75907-260-18, 75907-260-25, 75907-260-55, 75907-260-14, 75907-260-95 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 7c1b1f21-5342-b733-2043-89c290a24bde | ff2711de-dbd1-9957-86c6-8222eba8b712 | 2025-02-06 | Warnings | 7c1b1f21-5342-b733-2043-89c290a24bde ff2711de-dbd1-9957-86c6-8222eba8b712 |
Adverse event summaries are temporarily unavailable. Other product information remains available.