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NDC 50580-0437-03 Sudafed PE Sinus Congestion 10 mg/1 Details
Sudafed PE Sinus Congestion 10 mg/1
Sudafed PE Sinus Congestion 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 PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 50580-0437-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50580-0437 |
|---|---|
| Product ID | 50580-437_f767fdef-ab0e-f2e1-e053-6294a90aaac7 |
| Associated GPIs | |
| GCN Sequence Number | 058496 |
| GCN Sequence Number Description | phenylephrine HCl TABLET 10 MG ORAL |
| HIC3 | B6V |
| HIC3 Description | DECONGESTANTS, ORAL |
| GCN | 23944 |
| HICL Sequence Number | 002087 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Sudafed PE Sinus Congestion |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Johnson & Johnson Consumer Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50580-0437-03 (50580043703)
| NDC Package Code | 50580-437-03 |
|---|---|
| Billing NDC | 50580043703 |
| Package | 3 CARTON in 1 PACKAGE (50580-437-03) / 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2019-09-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |