FDA.reportPublic FDA data

Novalgina Pediatrico Cough and Cold

Manufacturer
HBC Pharma LLC | GADAL Laboratories, Inc
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:01

Label at a glance#

ProductNovalgina Pediatrico Cough and Cold Pediatrico
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product do not use more that directed

Stop use and ask a doctor

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Other Information:

Each 1 mls

Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).

Other Information:

OTHER SAFETY INFORMATION

  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature: Do not use if there is evidence of tampering

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelPackPack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1487369dextromethorphan HBr 7.5 MG / guaiFENesin 88 MG / phenylephrine HCl 2.5 MG in 1 mL Oral SolutionPSN4
1487369dextromethorphan hydrobromide 7.5 MG/ML / guaifenesin 88 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral SolutionSCD4
1487369dextromethorphan HBr 7.5 MG / guaifenesin 88 MG / phenylephrine HCl 2.5 MG per 1 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83057-0002-2Novalgina Pediatrico Cough and ColdPediatrico1 in 1 CARTONLIQUID14
83057-0002-2Novalgina Pediatrico Cough and ColdPediatrico60 mL in 1 BOTTLELIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83057-0002NOVALGINA PEDIATRICO COUGH AND COLD PEDIATRICO (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HBC PHARMA LLC]42 package rows20241105_f22979dc-e808-3461-e053-2a95a90a39d0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83057-000283057-0002-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2618ecdc-3eed-a69b-e063-6394a90a8024f22979dc-e808-3461-e053-2a95a90a39d02024-11-04WarningsExact identifier
spl id: 2618ecdc-3eed-a69b-e063-6394a90a8024
spl set id: f22979dc-e808-3461-e053-2a95a90a39d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.