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| Product NDC Code | 58657-504 | ||||
|---|---|---|---|---|---|
| Drug Name | Guaifenesin and dextromethorphan hydrobromide |
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| Type | Generic | ||||
| 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 | 996520 | ||||
| Application Number | M012 | ||||
| Labeler Name | Method Pharmaceuticals | ||||
| 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 Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 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 do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age adults and children 12 years and over 2 teaspoonfuls (TSP) every 4 hours children 6 to 12 years of age 1 teaspoonful (TSP) every 4 hours children under 6 years DO NOT USE
| adults and children 12 years and over | 2 teaspoonfuls (TSP) every 4 hours |
| children 6 to 12 years of age | 1 teaspoonful (TSP) every 4 hours |
| children under 6 years |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate
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 cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Guaifenesin and Dextromethorphan Hydrobromide Guaifenesin and Dextromethorphan Hydrobromide GLYCERIN FD&C RED NO. 40 SACCHARIN SODIUM HIGH FRUCTOSE CORN SYRUP MENTHOL SODIUM BENZOATE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN DEXTROSE ANHYDROUS CITRIC ACID
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 Method Pharmaceuticals NDC 58657-504-08 Guaifenesin and Dextromethorphan Hydrobromide Syrup 100 mg/10 mg/5 mL Expectorant Cough Suppressant Grape Flavor Non Drowsy • Alcohol Free FOR AGES 12 AND UP 8 fl. oz. (237 mL) Manufactured For: Method Pharmaceuticals, LLC Southlake, TX 76092 Rev. 02/2024 label
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.Other information store at room temperature 20°-25°C (68°-77°F) each 5 mL contains: sodium 3 mg
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 persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema cough 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 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.TAMPER-EVIDENT Do not use if seal cap is broken 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 1-877-250-3427
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 cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be a sign of a serious condition hypersensitive to any ingredients
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), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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