FDA Label for Novalgina Pediatrico Cough And Cold Pediatrico
View Indications, Usage & Precautions
Novalgina Pediatrico Cough And Cold Pediatrico Product Label
The following document was submitted to the FDA by the labeler of this product Hbc Pharma Llc. 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.) | Purpose |
Dextromethorphan Hydrobromide 7.5 mg ....................... | Cough Suppressant |
Guaifenesin 88 mg...................................................... | Expectorant |
Phenylephrine HCl 2.5 mg....................................................... | Decongestant |
Otc - Purpose
Uses:
- Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make the cough more productive.
- Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold. or inhaled irritants
- the intensity of coughing
- The impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Warnings
in a child who is taking 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 giving this product.
Do Not Use
in a child who is taking 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 giving this product.
Ask A Doctor Before Use
Ask a doctor before use if the child has
- Heart disease
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When Using This Product
When using this product do not use more that directed
Stop Use And Ask A Doctor
If nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough last more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Indications & Usage
Other Information:
Each 1 mls
Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
Other Information:
- Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
- Tamper Evident Feature: Do not use if there is evidence of tampering
Inactive Ingredient
Citric Acid, FD&C red no. 40, artificial flavors, glycerine, high fructose corn syrup, Hydroxyethyl Cellulose, methylparaben, propylene glycol, Propylparaben, purified water, sodium citrate, sorbitol solution, sucralose.
Dosage And Administration
Do not exceed recommended dose. Measure with the dosage device provided
Children 6 to under 12 years of age 2 ml every 6-8 hours
Children 2 to under 6 years of age 1 ml every 6-8 hours
Children under 2 years of age Consult a doctor
* Please review the disclaimer below.