Search by Drug Name or NDC
NDC 50580-0436-01 Sudafed PE Head Congestion Plus Pain 200; 10 mg/1; mg/1 Details
Sudafed PE Head Congestion Plus Pain 200; 10 mg/1; mg/1
Sudafed PE Head Congestion Plus Pain is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 50580-0436-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 50580-0436-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50580-0436 |
|---|---|
| Product ID | 50580-436_f767ddcc-8ce8-1940-e053-6294a90aedec |
| Associated GPIs | |
| GCN Sequence Number | 072215 |
| GCN Sequence Number Description | ibuprofen/phenylephrine HCl TABLET 200MG-10MG ORAL |
| HIC3 | B5G |
| HIC3 Description | DECONGESTANT-NSAID, COX NON-SPEC COMB. |
| GCN | 36337 |
| HICL Sequence Number | 036618 |
| HICL Sequence Number Description | IBUPROFEN/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Sudafed PE Head Congestion Plus Pain |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200; 10 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Johnson & Johnson Consumer Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203200 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50580-0436-01 (50580043601)
| NDC Package Code | 50580-436-01 |
|---|---|
| Billing NDC | 50580043601 |
| Package | 2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2019-06-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |