Tukol Max Action Cold, Flu And Sore Throat
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Genomma Lab Usa
Human Otc Drug
NDC 50066-313Tukol Max Action Cold, Flu And Sore Throat also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Genomma Lab Usa'. National Drug Code (NDC) number for Tukol Max Action Cold, Flu And Sore Throat is 50066-313. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Tukol Max Action Cold, Flu And Sore Throat drug includes Acetaminophen - 32.5 mg/mL Dextromethorphan Hydrobromide - 1 mg/mL Guaifenesin - 20 mg/mL Phenylephrine Hydrochloride - .5 mg/mL . The currest status of Tukol Max Action Cold, Flu And Sore Throat drug is Active.
Drug Information:
| Drug NDC: | 50066-313 |
| 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 Max Action Cold, Flu And Sore Throat |
| 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: | Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Genomma Lab Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Syrup |
| 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: | ACETAMINOPHEN - 32.5 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE - 1 mg/mL
GUAIFENESIN - 20 mg/mL
PHENYLEPHRINE HYDROCHLORIDE - .5 mg/mL
|
| 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: | 30 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 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
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1116572
|
| 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. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
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]
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]
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 |
|---|
| 50066-313-06 | 1 BOTTLE, PLASTIC in 1 CARTON (50066-313-06) / 177 mL in 1 BOTTLE, PLASTIC | 30 Dec, 2022 | 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:
Active ingredients (in each 20 ml) purposes acetaminophen 650mg pain reliever/fever reducer dextromethorphan hbr 20 mg cough suppressant guaifenesin 400 mg expectorant phenylephrine hcl 10 mg nasal decongestant
Product Elements:
Tukol max action cold, flu and sore throat acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine water glycerin propylene glycol sorbitol sodium benzoate sucralose characteristic medicinal
Indications and Usage:
Uses temporarily relieves these common cold and flu symptoms: nasal congestion cough minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 4 doses (20 ml each) in 24 hours, which is the maximum daily amount for this product. with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product. allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening, blisters and rash. if skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vominting, consult a doctor promptly. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's diseas
Read more...e), 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 liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days cough comes back or occuurs with fever, rash, or headache that lasts fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take: more than 4 doses (20 ml each) in 24 hours, which is the maximum daily amount for this product. with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product. allergy alert acetaminophen may cause severe skin reactions. symptoms may include: skin reddening, blisters and rash. if skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vominting, consult a doctor promptly. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are 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 liver disease heart disease high blood pressure thyroid disease diabetes a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not use more than directed stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days cough comes back or occuurs with fever, rash, or headache that lasts fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms.
When Using:
When using this product do not use more than directed
Dosage and Administration:
Directions do not take more than directed do not take more than 4 doses in 24 hours. this adult strength product is not intended for use in children under 12 years of age dose as follows or as directed by a doctor use dose cup provided age dose adults and children 12 years and older 20 ml every 4 hours children under 12 years of age do not use
Stop Use:
Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion or cough gets worse or lasts more than 7 days cough comes back or occuurs with fever, rash, or headache that lasts fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 177 ml bottle carton new look tukol ® max action cold, flu and sore throat acetaminophen/dextromethorphan hbr/ guaifenesin/phenylephrine hcl ages 12+ max strength relieves: ⦠minor aches & pain ⦠fever ⦠nasal & chest congestion ⦠cough 6 fl oz (177 ml) principal display panel - 177 ml bottle carton
Further Questions:
Questions or comments? 1-877-994-3666 monday to friday from 8 am to 6 pm, central time.