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NDC 63102-0101-16 ACTINEL 15; 200; 30 mg/5mL; mg/5mL; mg/5mL Details
ACTINEL 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
ACTINEL is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Actipharma, Inc. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE 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: 63102-0101-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63102-0101-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 63102-0101-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 63102-0101 |
|---|---|
| Product ID | 63102-101_7ffd904d-64c8-4328-bd53-7a99f3c535b4 |
| Associated GPIs | 43997303320990 |
| GCN Sequence Number | 060480 |
| GCN Sequence Number Description | guaifenesin/DM/pseudoephedrine SOLUTION 200-15-30 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 26642 |
| HICL Sequence Number | 000222 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ACTINEL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 15; 200; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Actipharma, Inc |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M012 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63102-0101-16 (63102010116)
| NDC Package Code | 63102-101-16 |
|---|---|
| Billing NDC | 63102010116 |
| Package | 474 mL in 1 BOTTLE (63102-101-16) |
| Marketing Start Date | 2014-09-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |