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| Product NDC Code | 72483-100 | ||||
|---|---|---|---|---|---|
| Drug Name | Resfridol antitussive |
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| Type | Brand | ||||
| Pharm 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 Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 2280291 | ||||
| Application Number | M012 | ||||
| Labeler Name | Laboratorios Alfa | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients and Purposes Active ingredients (in each 10 mL) Purposes Guaifenesin 200 mg ............................................................................ Expectorant Dextromethorphan HBr 30 mg.................................................. Cough suppressant
| Guaifenesin 200 mg ............................................................................ | Expectorant |
| Dextromethorphan HBr 30 mg.................................................. | Cough suppressant |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions do not exceed recommended dosage do not exceed 4 doses in a 24-hour period adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours children under 6 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to: drain bronchial tubes make coughs more productive
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 10 mL) Purposes Guaifenesin 200 mg ............................................................................ Expectorant Dextromethorphan HBr 30 mg.................................................. Cough suppressant
| Guaifenesin 200 mg ............................................................................ | Expectorant |
| Dextromethorphan HBr 30 mg.................................................. | Cough suppressant |
Spl product data elements
Usually a list of ingredients in a drug product.Resfridol Antitussive Guaifenesin, Dextromethorphan HBr SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN WATER SORBITOL ANHYDROUS CITRIC ACID FD&C RED NO. 40 SODIUM BENZOATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Resfridol Antitussive Syrup Cough Suppressant Expectorant Dextromethorphan Hbr and Guaifenesin 4 fl oz (120mL) Resfridol Antitussive
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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)
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information
Other information store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
Other information store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1-809-544-0222 (M-F) 9 AM to 5 PM Eastern or www.laboratoriosalfa.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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) Stop use and ask a doctor if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API