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NDC 72483-0100-04 Resfridol Antitussive 30; 200 mg/10mL; mg/10mL Details
Resfridol Antitussive 30; 200 mg/10mL; mg/10mL
Resfridol Antitussive is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Laboratorios Alfa. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
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: 72483-0100-04Last 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: 72483-0100-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 72483-0100 |
|---|---|
| Product ID | 72483-100_e39d9051-ad31-7afc-e053-2995a90a6091 |
| 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 | Resfridol Antitussive |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin, Dextromethorphan HBr |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 30; 200 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Laboratorios Alfa |
| Pharmaceutical Class | 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], Uncompetitive NMDA Receptor Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72483-0100-04 (72483010004)
| NDC Package Code | 72483-100-04 |
|---|---|
| Billing NDC | 72483010004 |
| Package | 1 BOTTLE in 1 BOX (72483-100-04) / 120 mL in 1 BOTTLE |
| Marketing Start Date | 2019-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 908f70e0-706b-1234-e053-2a95a90ade84 Details
Active ingredients and Purposes
Uses
Warnings
Ask a doctor or pharmacist before 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.
- have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Directions
Other information
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| RESFRIDOL ANTITUSSIVE
guaifenesin, dextromethorphan hbr suspension |
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| Labeler - Laboratorios Alfa (815941244) |
Revised: 7/2022
Document Id: e39d9051-ad31-7afc-e053-2995a90a6091
Set id: 908f70e0-706b-1234-e053-2a95a90ade84
Version: 3
Effective Time: 20220712