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NDC 69452-0394-64 Acetaminophen and Ibuprofen 250; 125 mg/1; mg/1 Details
Acetaminophen and Ibuprofen 250; 125 mg/1; mg/1
Acetaminophen and Ibuprofen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is ACETAMINOPHEN; IBUPROFEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 69452-0394-64Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Acetaminophen
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 69452-0394-64Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 69452-0394 |
|---|---|
| Product ID | 69452-394_04ccd213-0a71-bd26-e063-6294a90a728d |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Acetaminophen and Ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen and Ibuprofen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 250; 125 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; IBUPROFEN |
| Labeler Name | Bionpharma Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA216999 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69452-0394-64 (69452039464)
| NDC Package Code | 69452-394-64 |
|---|---|
| Billing NDC | 69452039464 |
| Package | 216 TABLET, FILM COATED in 1 BOTTLE (69452-394-64) |
| Marketing Start Date | 2023-09-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |