The following Structured Product Label (SPL) was submitted to the FDA by Hbc Pharma Llc for the product Novalgina Pediatrico Cough And Cold (NDC 83057-0002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active Ingredients:(in each 1 ml.) | Purpose |
Dextromethorphan Hydrobromide 7.5 mg ....................... | Cough Suppressant |
Guaifenesin 88 mg...................................................... | Expectorant |
Phenylephrine HCl 2.5 mg....................................................... | Decongestant |
Uses:
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.
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 if the child has
When using this product do not use more that directed
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Other Information:
Each 1 mls
Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
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.
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.
