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| Product NDC Code | 50066-533 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Tukol x-pecto miel multi symptom cold |
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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 | 1044949 | ||||||
| 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.DRUG FACTSActive ingredients (in each 5 mL tsp) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg Phenylephrine HCL, USP 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 Do not take more than 6 doses in any 24 hour period This adult strength product is not intended for use in children under 12 years of age Age - adults and children 12 years and over Dose - 2 teaspoons every 4 hours Age - children under 12 Dose - do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, FD and C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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.Purposes Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Tukol X-Pecto Miel Multi Symptom Cold DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 GLYCERIN HONEY PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE XANTHAN GUM HONEY
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.Tukol X-PECTO MIEL Cough & Cold product label Tukol ® X-PECTO MIEL DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING Dextromethorphan HBr / Guaifenesin / Phenylephrine HCL Cough Suppressant / Expectorant / Nasal Decongestant Tukol ® X-PECTO MIEL Cough & Cold Quiets Cough Thins & loosens Phlegm Clears Nasal Congestion NATURAL HONEY FLAFOR Ages / 12+ 4 FL OZ (118 ml) 2000006935 6 50066 00042 0 LOT no. Exp. Distributed by Genomma Lab USA Inc. Houston TX, 77027 BX-035 Rev. 02 Genomma Lab. ® rege Tokul X-PECTO 533-24 Box VER2 Tokul X-PECTO 533-24 Btl VER2
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 any other oral nasal decongestant or stimulant. When using this product do not use more than directed. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
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. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each teaspoon contains: sodium 3 mg store at 20‐25 ° C (68‐77 ° F). Do not refrigerate. dosage cup provided
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) 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 symptoms do not get better within 7 days, or are accompanied by 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
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 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.
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