Search by Drug Name or NDC
NDC 50580-0785-04 Childrens SUDAFED PE Cold plus Cough 5; 2.5 mg/5mL; mg/5mL Details
Childrens SUDAFED PE Cold plus Cough 5; 2.5 mg/5mL; mg/5mL
Childrens SUDAFED PE Cold plus Cough is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 50580-0785-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 50580-0785-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50580-0785 |
|---|---|
| Product ID | 50580-785_f79f9b66-79d2-a473-e053-6294a90a9e4c |
| Associated GPIs | |
| GCN Sequence Number | 062332 |
| GCN Sequence Number Description | dextromethorphan/phenylephrine LIQUID 5-2.5 MG/5 ORAL |
| HIC3 | B4L |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT COMBINATIONS |
| GCN | 98110 |
| HICL Sequence Number | 000395 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Childrens SUDAFED PE Cold plus Cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan hydrobromide and Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Johnson & Johnson Consumer Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 50580-0785-04 (50580078504)
| NDC Package Code | 50580-785-04 |
|---|---|
| Billing NDC | 50580078504 |
| Package | 1 BOTTLE in 1 CARTON (50580-785-04) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2008-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |