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| Product NDC Code | 49873-306 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Stona cough |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-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], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 1245616 | ||||||
| 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 each tablet) Dextromethorphan hydrobromide 15mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 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 2 tablets every 6 to 8 hours, not to exceed 8 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age: take 1 tablet every 6 to 8 hours, not to exceed 4 tablets in 24 hours, or as directed by a doctor children under 6 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium hydroxide, anhydrous dibasic calcium phosphate, calcium carbonate, carmellose, carnauba wax, croscarmellose sodium, dewaxed orange shellac, , FDandC Yellow No. 6 aluminum lake as color additive, glycyrrhiza extract, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, partially hydrolyzed polyvinyl alcohol, polyethylene glycol 6000, propylene glycol, silicon dioxide, simethicone, sugar, talc, titanium dioxide
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 and nasal congestion 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.Purposes Dextromethorphan hydrobromide Cough suppressant Guaifenesin Expectorant Phenylephrine hydrochloride Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Stona Cough dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride AMMONIA CALCIUM CARBONATE CARBOXYMETHYLCELLULOSE CARNAUBA WAX CROSCARMELLOSE SODIUM SHELLAC CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 ALUMINUM OXIDE LICORICE HYDROXYPROPYL CELLULOSE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYVINYL ALCOHOL POLYETHYLENE GLYCOL 6000 PROPYLENE GLYCOL SILICON DIOXIDE DIMETHICONE SUCROSE TALC TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SATO;5
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.Carton
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 before use if you have ■ heart disease ■ thyroid disease ■ high blood pressure ■ high fever ■ diabetes ■ difficulty in urination due to enlarged prostate gland ■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are ■ taking a prescription drug and do not know if it contains an MAOI
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 ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) ■ for 2 weeks after the stopping the MAOI drug
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 overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each tablet contains calcium 30 mg ■ keep container tightly closed ■ protect from light
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 ■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition) ■ nervousness, dizziness, or sleeplessness occur ■ cough is accompanied by rash or persistent headache ■ symptoms are accompanied by fever
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ do not exceed recommended dosage
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 Do not use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease) ■ for 2 weeks after the stopping the MAOI drug Ask a doctor before use if you have ■ heart disease ■ thyroid disease ■ high blood pressure ■ high fever ■ diabetes ■ difficulty in urination due to enlarged prostate gland ■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are ■ taking a prescription drug and do not know if it contains an MAOI When using this product ■ do not exceed recommended dosage Stop use and ask a doctor if ■ symptoms persist for more than 1 week or cough tends to recur (a persistent cough may be sign of a serious condition) ■ nervousness, dizziness, or sleeplessness occur ■ cough is accompanied by rash or persistent headache ■ symptoms are accompanied by fever If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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