Tukol A
Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Genomma Lab Usa, Inc.
Human Otc Drug
NDC 50066-536Tukol A also known as Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'Genomma Lab Usa, Inc.'. National Drug Code (NDC) number for Tukol A is 50066-536. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Tukol A drug includes Dextromethorphan Hydrobromide - 5 mg/5mL Guaifenesin - 50 mg/5mL Phenylephrine Hydrochloride - 2.5 mg/5mL . The currest status of Tukol A drug is Active.
Drug Information:
| Drug NDC: | 50066-536 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Tukol A |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Genomma Lab Usa, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DEXTROMETHORPHAN HYDROBROMIDE - 5 mg/5mL
GUAIFENESIN - 50 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 2.5 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 09 Jun, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Genomma Lab USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1370205
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0650066000539
|
| UPC stands for Universal Product Code. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 9D2RTI9KYH
495W7451VQ
04JA59TNSJ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Expectorant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Respiratory Secretion Viscosity [PE]
Increased Respiratory Secretions [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic 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]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50066-536-24 | 118 mL in 1 BOTTLE (50066-536-24) | 09 Jun, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose cough suppressant expectorant nasal decongestant
Product Elements:
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
Indications and Usage:
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
Warnings:
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.
When Using:
When using this product do not use more than directed
Dosage and Administration:
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
Stop Use:
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.
Package Label Principal Display Panel:
Children's tukol bottle label childrenâs 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 childrenâs tukol ® cough suppressant/expectorant/nasal decongestant dextromethorphan hbr | guaifenesin | phenylephrine hci do not use if printed seal under cap is torn or missing childrenâs 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
Further Questions:
Questions or comments? 1 877 99 genom (43666)