FDA Label for Tusnel Pediatric Drops
View Indications, Usage & Precautions
Tusnel Pediatric Drops Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals 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 (1 mL)
Guaifenesin 25 mg
Phenylephrine HCl 1.25 mg
Otc - Purpose
Purpose
Expectorant
Nasal Decongestant
Indications & Usage
Uses
- Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
- Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.
Warnings
Warnings
Do not use in child whos 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 your doctor or pharmacist before giving this product.
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
- a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- do not exceed the recommended dosage.
- nervousness, dizziness or sleeplessness occurs
- symptoms do not get better within 7 days or accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
When using this product
Stop use and ask doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case 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 2 to under 6 years of age | 24-47 lbs | Take 2 mL every 4-6 hours |
| Children under 2 years of age | Under 24 lbs | Ask a doctor |
Inactive Ingredient
Inactive ingredients: Artifical and natural flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.
Otc - Questions
Questions or Comments? 1-866-595-5598
Package Label.Principal Display Panel
* Please review the disclaimer below.