Novalgina

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 Children Cough and Cold
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:(in each 10 ml.)Purpose

Acetaminophen 250 mg ........................................................

Analgesic

Dextromethorphan Hydrobromide 13.33 mg .......................

Cough Suppressant

Guaifenesin USP 200 mg......................................................

Expectorant

Phenylephrine HCl 5 mg.......................................................

Decongestant

OTC - PURPOSE SECTION

Uses:

  • For temporary relief og Bronchial and Nasal congestion
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

WARNINGS SECTION

Warnings

Do not exceed recommended dosage


Liver Warning this product contatins Acetaminophen. Severe liver damage may occur if

OTC - DO NOT USE SECTION


  • Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • Child takes more than 5 doses in 24 hours
  • Taken with other drugs containing Acetaminophen.
  • Adult has 3 or more alcoholic drinks every day while using this product
  • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
  • Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
  • If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
  • If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
  • Avoid alcoholic beverage while taking this product.
  • Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist

Stop use and ask a doctor

  • Nervousness, dizziness or sleeplessness occurs.
  • Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.

OTC - ASK DOCTOR SECTION

Ask doctor before use if you have

  • Cough that occurs with too much phlegm(mucus)
  • Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
  • The user has Liver diseases
  • The user us taking the blood thinning drug Warfarin

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not exceed 6 doses in any 24-hour period.

AGE
DOSE
Adults and Children 12 years and over
10 ml (2 tsps) every 6 hours
Children 6 to under 12 years of age
5 ml (1 tsp) every 6 hours
Children under 6 years of age
Do not  use



INDICATIONS & USAGE SECTION

Other Information:

  • Each 10 mls contains: sodium 4 mg
  • Store between 15 - 30 degrees Celsius (59 - 86 Fahrenheit).
  • Tamper Evident Feature:Do not use if seal under cap is torn, broken or missing.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Aloe Vera, Citric Acid, Disodium EDTA, FDC Red #40, Hydroxyethyl Cellulose, Natural Strawberry Flavor, Propylene Glycol USP, Purified Water, Sodium Benzoate, Sorbitol 70% USP, Sucralose.

Questions or Comments

OTC - QUESTIONS SECTION

Call Weekdays from 9:30 AM to 5PM EST at Tel 800-491-7908

Made in U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children Cough and Cold LabelChildren Cough and Cold Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral SolutionPSN4
1790651acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD4
1790651acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY4
1790651acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY4
1790651APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/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
83057-0001-6NovalginaChildren Cough and Cold180 mL in 1 BOTTLELIQUID1804
83057-0001-6NovalginaChildren Cough and Cold1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83057-0001NOVALGINA CHILDREN COUGH AND COLD (ACETAMINOFEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [HBC PHARMA, LLC]4Legacy NDC, 2 package rows20241105_eb3f0cb2-03d4-1776-e053-2a95a90acf37.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83057-000183057-0001-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
2618f02b-442e-afe3-e063-6394a90adc6feb3f0cb2-03d4-1776-e053-2a95a90acf372024-11-04WarningsExact identifier
spl id: 2618f02b-442e-afe3-e063-6394a90adc6f
spl set id: eb3f0cb2-03d4-1776-e053-2a95a90acf37

Reported adverse events (FAERS/openFDA)#

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