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| Product NDC Code | 50066-536 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tukol a |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], 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 | LIQUID | ||||||
| RxCUI drug identifier | 1370205 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Genomma Lab USA, Inc. | ||||||
| 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 DRUG FACTS Active ingredients (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 50 mg Phenylephrine HCL, USP 2.5 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 age dose children 6 to 12 years 2 tsp (10 mL) every 4 hours children 4 to 6 years 1 tsp (5 mL) every 4 hours children under 4 years do not use do not exceed 6 doses in a 24-hour period use enclosed dosage cup tsp = teaspoon, mL = milliliter
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, glycerin, purified water, sodium benzoate, sorbitol, 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 help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold - nasal congestion - cough due to minor throat and bronchial irritation
Purpose
Information about the drug product’s indications for use.Purpose Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM GRAPE FLAVOR
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.Children's Tukol Bottle Label Children’s Tuko l ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI Ages 4+ Cough and Cold Gets rid of phlegm Quiets Cough Clears nasal congestion Grape Flavor 4 FL OZ (118 ml) Drug Facts Active in gredients Purpose (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 5 mg ...............Cough suppressant Guaifenesin, 50 mg. .......................................Expectorant Phenylephrine HCI, 2.5 mg ................... Nasal decongestant Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation Warnings Do not use in a child who is 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 the child has • heart disease • diabetes • high blood pressure • thyroid disease • cough that lasts or is chronic such as occurs with asthma • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant. When using this product • do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • symptoms do not get better within 7 days or are accompanied by fever • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. Drug Facts (continued) Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Directions • do not exceed 6 doses in a 24-hour period • use enclosed dosage cup • tsp = teaspoon, mL = milliliter age dose children 6 to 12 years 2 teaspoons (10 mL) every 4 hours children 4 to 6 years 1 teaspoons (5 mL) every 4 hours children under 4 years do not use Other information • each 5 mL contains: sodium 3 mg • store at room temperature Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum Questions or comments? 1-877-99 GENOM (43666) Distributed by Genomma Lab USA., Houston, TX, 77027 TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. LR-063 Rev. 2 PEEL HERE Tukol-BTL-037-RV2
Children's Tukol Box Label Children’s Tukol ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Children’s Tukol ® Cough Suppressant/Expectorant/Nasal Decongestant Dextromethorphan HBr | Guaifenesin | Phenylephrine HCI Ages 4+ Cough and Cold Gets rid of phlegm Quiets Cough Clears nasal congestion Grape Flavor 4 FL OZ (118 ml) LOT No. Exp. Drug Facts Active ingredients Purpose (in each 5 mL, 1 teaspoon) Dextromethorphan HBr, 5 mg ...............Cough suppressant Guaifenesin, 50 mg. .......................................Expectorant Phenylephrine HCI, 2.5 mg ................... Nasal decongestant Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation Warnings Do not use in a child who is 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 the child has • heart disease • diabetes • high blood pressure • thyroid disease • cough that lasts or is chronic such as occurs with asthma • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant. When using this product • do not use more than directed Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • symptoms do not get better within 7 days or are accompanied by fever • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Distributed by Genomma Lab USA Inc., Houston, TX 77027 Genomma Lab. ® 3 66975-3 8/17 Drug Facts (continued) Directions • do not exceed 6 doses in a 24-hour period • use enclosed dosage cup • tsp = teaspoon, mL = milliliter age dose children 6 to 12 years 2 teaspoons (10 mL) every 4 hours children 4 to 6 years 1 teaspoons (5 mL) every 4 hours children under 4 years do not use Other information • each 5 mL contains: sodium 3 mg • store at room temperature Inactive ingredients citric acid, FD&C Blue # 1, FD&C Red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum Questions or comments? 1-877-99 GENOM (43666) BX-037 Rev. 02 2FTAP1MUEWW1B Tukol-BX-037-RV2
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 the child has heart disease diabetes high blood pressure thyroid disease cough that lasts or is chronic such as occurs with asthma cough that occurs with too much phlegm (mucus)
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 the child is taking any other oral nasal decongestant or stimulant.
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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each 5 mL contains: sodium 3 mg store at room temperature
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 99 GENOM (43666)
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 nervousness, dizziness, or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by a fever 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.
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 use more than directed
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 in a child who is 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 child's 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