Other
Drug Facts
Do not exceed recommended dosage.
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
Tukol Sugar Free Cough And Cold Syrup
FDA Label NDC 50066-505
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 Sugar Free Cough And Cold (NDC 50066-505). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, 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 10 mL) | Purposes |
|---|---|
| Dextromethorphan HBr, 20 mg | Cough Suppressant |
| Guaifenesin, 200 mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold,
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
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
- 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 - Stop Use
Stop use and ask a doctor if 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 (1-800-222-1222).
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,
- measure only with dosing cup provided,
- keep dosing cup with product,
- TSP = teaspoon
- mL = milliliter
- dose as follows:
| age | dose |
|---|---|
| adults and children 12 years and over | 10 mL (2 teaspoons) every 4 hours |
| children under 12 years | do not use |
Other Information
- store at 15-30°C (59-86°F). Do not refrigerate,
- alcohol-frees,
- see bottom panel for lot number and expiration date.
Inactive Ingredients
Anhydrous citric acid, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum.
Questions Or Comments?
1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.
Principal Display Panel - 118 Ml Bottle Carton
Dextromethorphan HBr / Guaifenesin
Tukol®
SUGAR FREE
0%
COUGH & COLD
Ages
12+
HBP
HIGH BLOOD PRESSURE
RELIEVES COUGH
RELIEVES CHEST CONGESTION
SUGAR-FREE FORMULA
FOR DIABETICS
4 FL OZ (118 mL)
Principal Display Panel (118 mL Bottle Carton)
* Please review the disclaimer below.
