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 1 mL (dropperful) Purpose
Guaifenesin........................25mg................................................Expectorant
Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant
Otc - Purpose
Uses
- temporarily relieves these symptoms due to the common cold and thin bronchial secretions to make coughs more productive
Warnings
WarningsDo not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving 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 Stop use and ask a doctor if
- 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
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 2 to under 6 years of age | 24 -47 lbs | Take 2 mL (two dropperfuls) every 4 to 6 hours |
| Children under 2 years of age | Under 24 lbs | ask a doctor |
Indications & Usage
Other information
- store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]
- Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
- Oral dosing device enclosed
Inactive Ingredient
Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.
Otc - Questions
Questions or Comments? 1-866-595-5598
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