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| Product NDC Code | 50066-302 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tukol honey daytime cold and flu |
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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 | SYRUP | ||||||
| RxCUI drug identifier | 1113705 | ||||||
| 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 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal Decongestant
| Active Ingredients (in each 30 mL) | Purpose |
|---|---|
| Pain reliever/Fever reducer | |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| 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 do not take mare than directed do not take more than 4 doses in any 24 hours this adult strength product is not inteded for use in children under 12 years of age measyre only with dosing cup provided keep dosing cup with product mL = mililiter TBSP = tablespoon dose as follows age dose adults and children 12 years of age and over 30 mL (2 tablespoons) every 4 hours Children under 12 years Do not use When using Day Time and Night Time products, carefully read each label to ensure correct dosing.
| age | dose |
|---|---|
| adults and children 12 years of age and over | 30 mL (2 tablespoons) 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 Citric acid, FD&C Yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
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 cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough due to minor throat and bronchial irritation temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Active Ingredients (in each 30 mL) Purpose Acetaminophen 650 mg Pain reliever/Fever reducer Dextromethorphan HBr 20 mg Cough suppressant Phenylephrine HCl 10 mg Nasal Decongestant
| Active Ingredients (in each 30 mL) | Purpose |
|---|---|
| Pain reliever/Fever reducer | |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Phenylephrine HCl 10 mg | Nasal Decongestant |
Spl product data elements
Usually a list of ingredients in a drug product.Tukol Honey Daytime Cold and Flu Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride WATER GLYCERIN PROPYLENE GLYCOL SORBITOL SODIUM BENZOATE SUCRALOSE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 HONEY ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 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 - 118 ml Bottle Carton Day Time Tukol ® HONEY MULTI SYMPTOM COLD & FLU Acetaminophen / Dextromethorphan HBr / Phenylephrine HCl Ages 12+ NATURAL HONEY FLAVOR Relieves: HEADACHE, SORE THROAT, FEVER MINOR ACHES AND PAINS NASAL CONGESTION AND COUGH 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 liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive 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 two 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.
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 you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back, or occurs with rash or headache that lasts. new symptoms occur 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 (see overdose warning ) avoid alcoholic drinks
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 30 mL contains sodium: 18 mg store between 15-30 o C (59-86 o 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 The product contains Acetaminophen. Severe liver damage may occur if you take more than 4 doses (30 mL each) 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 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 vomiting, 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two 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 thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma or emphysema cough accompanied by excessive 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 (see overdose warning ) avoid alcoholic drinks Stop use and ask a doctor if you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back, or occurs with rash or headache that lasts. 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. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as 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