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NDC 47682-0162-99 Dover Sudanyl PE 5 mg/1 Details
Dover Sudanyl PE 5 mg/1
Dover Sudanyl PE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. 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: 47682-0162-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 47682-0162 |
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Product ID | 47682-162_da45030a-aa85-5d9d-e053-2a95a90a4cb2 |
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 | Dover Sudanyl PE |
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 | 5 |
Active Ingredient Units | mg/1 |
Substance Name | PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | Unifirst First Aid Corporation |
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
Package Images


NDC 47682-0162-99 (47682016299)
NDC Package Code | 47682-162-99 |
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Billing NDC | 47682016299 |
Package | 2 TABLET, FILM COATED in 1 PACKET (47682-162-99) |
Marketing Start Date | 2008-12-30 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d7d62ac1-1333-4366-884b-26537766ce38 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Do not use
- If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
205R Medique Medi-Phenyl Label
Dover Sudanyl Label
INGREDIENTS AND APPEARANCE
MEDIQUE MEDI-PHENYL
phenylephrine hydrochloride tablet, film coated |
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DOVER SUDANYL PE
phenylephrine hydrochloride tablet, film coated |
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Labeler - Unifirst First Aid Corporation (832947092) |
Revised: 3/2022
Document Id: da45030a-aa85-5d9d-e053-2a95a90a4cb2
Set id: d7d62ac1-1333-4366-884b-26537766ce38
Version: 10
Effective Time: 20220315