FDA Label for Tusnel Pediatric
View Indications, Usage & Precautions
Tusnel Pediatric Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division. 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.
Otc - Active Ingredient
Active Ingredients(in each 5 ml tsp.) Purpose
Dextromethorphan HBr........5mg..................................................Cough Suppressant
Guaifenesin........................50mg................................................Expectorant
Pseudoephedrine HCl..........15mg..................................................Nasal Decongestant
Otc - Purpose
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Warnings
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.
Otc - Do Not Use
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that occurs with too much phlegm (mucus)
- a persistent or chronic cough such as occurs with asthma
- do not exceed recommended dosage
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign of a serious condition.
When using this product
Stop use and ask a doctor if
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.
Dosage & Administration
Directions Do not exceed more than 4 doses in any 24-hour period
or as directed by a doctor.
| Age | Weight | Dose |
| Children 6 to under 12 years of age | 45 lbs to under 95 lbs | Take 2 teaspoonfuls (10 mL) every 4 to 6 hours |
| Children 2 to under 6 years of age | 25 lbs to under 45 lbs | Take 1 teaspoonful (5mL) every 4 to 6 hours |
| Children under 2 years of age | Under 25 lbs | ask a doctor |
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.
Inactive Ingredient
Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos
Otc - Questions
Questions or Comments? 1-866-595-5598
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