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| Product NDC Code | 50066-505 | ||||
|---|---|---|---|---|---|
| Drug Name | Tukol sugar free cough and cold |
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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 | 996520 | ||||
| Application Number | M012 | ||||
| Labeler Name | Genomma Lab USA | ||||
| 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 10 mL) Purposes Dextromethorphan HBr, 20 mg Cough Suppressant Guaifenesin, 200 mg Expectorant
| Dextromethorphan HBr, 20 mg | Cough Suppressant |
| Guaifenesin, 200 mg | Expectorant |
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 strength product is not intended for use in children under 12 years of age, measure only with dosing cup provided, keep dosing cup with product, TSP = teaspoon mL = milliliter dose as follows: age dose adults and children 12 years and over 10 mL (2 teaspoons) every 4 hours children under 12 years do not use
| age | dose |
|---|---|
| adults and children 12 years and over | 10 mL (2 teaspoons) every 4 hours |
| children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.
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.Active ingredients (in each 10 mL) Purposes Dextromethorphan HBr, 20 mg Cough Suppressant Guaifenesin, 200 mg Expectorant
| Dextromethorphan HBr, 20 mg | Cough Suppressant |
| Guaifenesin, 200 mg | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.Tukol Sugar Free Cough and Cold Dextromethorphan Hydrobromide and Guaifenesin ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN
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 - 118 mL Bottle Carton Dextromethorphan HBr / Guaifenesin Tukol ® SUGAR FREE 0% COUGH & COLD Ages 12+ HBP HIGH BLOOD PRESSURE RELIEVES COUGH RELIEVES CHEST CONGESTION SUGAR-FREE FORMULA FOR DIABETICS 4 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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
Distributed by: Genomma Lab USA Inc., Houston, TX 77098
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.
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) 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.
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 (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 15-30°C (59-86°F). Do not refrigerate, alcohol-frees, see bottom panel for lot number and expiration date.
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. 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. 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. Do not exceed recommended dosage. 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 (1-800-222-1222).
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