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Drug Facts
Distributed by: Genomma Lab USA Inc., Houston, TX, 77027
Tukol Cough And Cold Honey Flavor Syrup
FDA Label NDC 50066-534
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Tukol Cough And Cold Honey Flavor (NDC 50066-534). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL tsp) | Purpose |
|---|---|
| Dextromethorphan HBr,10 mg | Cough Suppressant |
| Guaifenesin, 100 mg | Expectorant |
| Phenylephrine HCl, 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
Otc - Do Not Use
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.
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant
Do not exceed recommended dosage
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 | dose |
|---|---|
| adults and children 12 years and over | 2 teaspoons (10 mL) every 4 hours |
| children under 12 | do not use |
Other Information
- each teaspoon contains: sodium 3 mg
- store at 20-25°C (68-77°F). Do not refrigerate
- dosage cup provided
Inactive Ingredients
anhydrous citric acid, FD&C yellow # 6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions Or Comments?
1-877-99 GENOM (43666)
Monday to Friday from 8 am to 6 pm, Central time.
Principal Display Panel - 118 Ml Bottle Carton
Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl
Tukol®
X-PECTO HONEY
COUGH & COLD
- Quiets Cough
- Thins & loosens Phlegm
- Clears Nasal Congestion
NATURAL HONEY FLAVOR
Ages 12+
4 FL OZ (118 ml)
Principal Display Panel (118 ml Bottle Carton)
* Please review the disclaimer below.
