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| Product NDC Code | 49873-302 | ||||
|---|---|---|---|---|---|
| Drug Name | Stona cough |
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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 | SYRUP | ||||
| RxCUI drug identifier | 1234473 | ||||
| Application Number | M012 | ||||
| Labeler Name | Sato Pharmaceutical Co., Ltd. | ||||
| 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 ( in 10 mL) Dextromethorphan hydrobromide 30 mg Guaifenesin 200 mg
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 ■Adults and children 12 years of age and over: Take 10mL every 6 – 8 hours, not to exceed 30mL in 24 hours, or as directed by a doctor. ■Children under 12 years: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol, beta-cyclodextrin, butylparaben, calcium chloride, caramel, citric acid, flavor, glycyrrhiza (licorice) extract, propylparaben, sodium benzoate, sodium saccharin, sugar, 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 For the temporary relief of cough due to the common cold. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Purpose
Information about the drug product’s indications for use.Purpose Dextromethorphan hydrobromide Cough suppressant Guaifenesin Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Stona Cough dextromethorphan hydrobromide, guaifenesin ALCOHOL BETADEX BUTYLPARABEN CALCIUM CHLORIDE CARAMEL CITRIC ACID MONOHYDRATE GLYCYRRHIZA GLABRA PROPYLPARABEN SODIUM BENZOATE SACCHARIN SODIUM SACCHARIN SUCROSE WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN cherry brandy
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.stonacoughsyrcartA.jpg Carton, panels 1, 2
stonacoughsyrcartB.jpg Carton, panels 3, 4
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product ■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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ■for a persistent or chronic cough such as occurs with smoking, asthma, or emphysema. ■if cough is accompanied by excessive phlegm (mucos) unless directed by a doctor.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
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 Enter section text here Do not use this product ■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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. ■for a persistent or chronic cough such as occurs with smoking, asthma, or emphysema. ■if cough is accompanied by excessive phlegm (mucos) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a health professional before use.
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