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| Product NDC Code | 50066-305 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tukol max action sinus liquid |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SYRUP | ||||||
| RxCUI drug identifier | 1116568 | ||||||
| Application Number | part341 | ||||||
| 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 20 mL) Purposes Acetaminophen 650mg Pain reliever Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant
| Pain reliever | |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
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 take only as recommended (see Overdose warning ) use dosage cup mL = milliliter do not take more than 6 doses in any 24-hour period Age Dose Adults and children 12 years and older 20 mL every 4 hours Children under 12 years of age Do not use
| Age | Dose |
|---|---|
| Adults and children 12 years and older | 20 mL 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 Anhydrous citric acid, edetate disodium, FD&C yellow no. 6, flavor, glycerin, propylene glycol, propyl gallate, 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 temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure temporarily promotes nasal and sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Purpose
Information about the drug product’s indications for use.Active ingredients (in each 20 mL) Purposes Acetaminophen 650mg Pain reliever Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant
| Pain reliever | |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Spl product data elements
Usually a list of ingredients in a drug product.Tukol Max Action Sinus Liquid Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride Acetaminophen Acetaminophen Guaifenesin Guaifenesin PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE WATER Glycerin Propylene Glycol Sorbitol Sodium benzoate Sucralose Amber to yellow
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 - 177 ml Bottle Carton NEW Tukol ® MAX ACTION SINUS Headache and Congestion Acetaminophen / Guaifenesin / Phenylephrine HCl For Ages 12 & Over NATURAL GINGER FLAVOR ♦ SINUS CONGESTION ♦ HEADACHE ♦ EXPECTORANT 6 FL OZ (177 ml) PRINCIPAL DISPLAY PANEL - 177 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 77027
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 liver disease heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema 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 you are taking the blood thinning drug warfarin.
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 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 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. for children under 12 years of age
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call weekdays from 8 AM to 6 PM EST at 1-877-994-3666
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 occur redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with 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
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 each 20 mL contains: sodium 10 mg dosage cup provided store between 15-30°C (59-86°F) do not refrigerate
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 Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters, rash. If a skin reaction occurs, stop use and seek medical help right away. 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 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. for children under 12 years of age Ask a doctor before use if you have liver disease heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) 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 nervousness, dizziness or sleeplessness occur redness or swelling is present symptoms do not get better within 7 days or are accompanied by a fever fever gets worse or lasts more than 3 days new symptoms occur cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. 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. Overdose warning 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 for adults as well as for children even if you do not notice any signs or symptoms.
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