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| Product NDC Code | 83057-0002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Novalgina pediatrico cough and cold pediatrico |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1487369 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | HBC Pharma LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients:(in each 1 ml.) Purpose Dextromethorphan Hydrobromide 7.5 mg ....................... Cough Suppressant Guaifenesin 88 mg...................................................... Expectorant Phenylephrine HCl 2.5 mg....................................................... Decongestant
| Active Ingredients:(in each 1 ml.) | Purpose |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Other Information: Each 1 mls Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
Purpose
Information about the drug product’s indications for use.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
Spl product data elements
Usually a list of ingredients in a drug product.Novalgina Pediatrico Cough and Cold Pediatrico Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl METHYLPARABEN PROPYLPARABEN FD&C RED NO. 40 GLYCERIN CITRIC ACID MONOHYDRATE HIGH FRUCTOSE CORN SYRUP HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) PROPYLENE GLYCOL WATER SODIUM CITRATE SORBITOL SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.label Pack
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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)
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information: Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit). Tamper Evident Feature: Do not use if there is evidence of tampering
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product When using this product do not use more that directed
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API