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| Product NDC Code | 52083-600 | ||||
|---|---|---|---|---|---|
| Drug Name | G-zyncof |
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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 | 1113368 | ||||
| Application Number | M012 | ||||
| Labeler Name | Kramer Novis | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 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. mL = milliliter age dose Adults and children 12 years of age and over 1 teaspoon (5mL) every 4 hours Children under 12 years of age do not use
| age | dose |
| Adults and children 12 years of age and over | 1 teaspoon (5mL) every 4 hours |
| Children under 12 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, eucalyptus oil, flavors, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
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 as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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.G-ZYNCOF Dextromethorphan HBr and Guaifenesin CITRIC ACID MONOHYDRATE EUCALYPTUS OIL MENTHOL, UNSPECIFIED FORM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN GLYCERIN GRAPE
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 LABEL G ZYNCOF UPDATED
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Directions: (The following changes were made) mL=milliliter A table was included with the dosage instructions according to age: age dose Adults and children 12 years of age and over 1 teaspoon (5mL) every 4 hours Children under 12 years of age do not use
| age | dose |
| Adults and children 12 years of age and over | 1 teaspoon (5mL) every 4 hours |
| Children under 12 years of age | do not use |
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 Tamper evident feature: Do not use if printed security seal is torn, broken or missing. Store at controlled room temperature 15°-30°C (59° to 86°F). Avoid excessive heat or humidity.
NDC 52083-600-16 G-ZYNCOF® Compare to Zyncof® Dextromethrophan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT SUGAR FREE & ALCOHOL FREE NO DYE - NO SACCHARIN - NO ASPARTAME 16 Fl. oz. (473mL) KramerNovis Pharmaceuticals within reach of patients Manufactured in USA with imported ingredients for Kramer Novis. San Juan, PR 00917 www.kramernovis.com
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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not use more than directed.
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.
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, comes back, 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 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