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NDC 50580-0434-01 Sudafed Sinus 12 Hour Pressure plus Pain 220; 120 mg/1; mg/1 Details
Sudafed Sinus 12 Hour Pressure plus Pain 220; 120 mg/1; mg/1
Sudafed Sinus 12 Hour Pressure plus Pain is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen 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: 50580-0434-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 50580-0434-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 50580-0434 |
|---|---|
| Product ID | 50580-434_f78d1bbf-afcb-4126-e053-6294a90af7ec |
| Associated GPIs | |
| GCN Sequence Number | 050606 |
| GCN Sequence Number Description | naproxen sodium/pseudoephedrin TAB ER 12H 220-120MG ORAL |
| HIC3 | B5G |
| HIC3 Description | DECONGESTANT-NSAID, COX NON-SPEC COMB. |
| GCN | 17708 |
| HICL Sequence Number | 011358 |
| HICL Sequence Number Description | NAPROXEN SODIUM/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Sudafed Sinus 12 Hour Pressure plus Pain |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen sodium and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 220; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Johnson & Johnson Consumer Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076518 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50580-0434-01 (50580043401)
| NDC Package Code | 50580-434-01 |
|---|---|
| Billing NDC | 50580043401 |
| Package | 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2019-06-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |