FDA Label for Tukol Children Cough And Congestion
View Indications, Usage & Precautions
Tukol Children Cough And Congestion Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Do not exceed recommended dosage.
Distributed by:
Genomma Lab USA Inc.,
Houston, TX 77098
Otc - Purpose
| Active Ingredient (in each 5 mL or 1 teaspoon) | Purpose |
| Dextromethorphan HBr, 5 mg | Cough Suppressant |
| Guaifenesin, 50 mg | Expectorant |
| Phenylephrine HCl, 2.5 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 in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- 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 persistant headache. These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Directions
- Do not take more than 6 doses in any 24 hour period
- measure only with dosing cup provided
- keep dosing cup with product
- TSP = teaspoon
| age | dose |
|---|---|
| children 6 to under 12 years | 2 teaspoons (10 mL) every 4 hours |
| children 4 to under 6 years | 1 teaspoon (5 mL) every 4 hours |
| children under 4 years | do not use |
Other Information
- each teaspoon (5 mL) contains: sodium 3 mg
- store at 15-30°C (59-86°F). Do not refrigerate.
Inactive Ingredients
citric acid, FD&C blue #1, FD&C red #40, flavor, glyverin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-877-994-3666
Principal Display Panel - 118 Ml Bottle Carton
Tukol®
Children's
COUGH & CONGESTION
Dextromethorphan HBr / Guaifenesin / Phenylephrine HCl
Ages
4+
Relieves:
- COUGH
- NASAL CONGESTION
- CHEST CONGESTION
4 FL OZ (118 ml)
* Please review the disclaimer below.