NOVALGINA PEDIATRICO COUGH AND COLD PEDIATRICO- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Novalgina Pediatrico Cough and Cold by

Drug Labeling and Warnings

Novalgina Pediatrico Cough and Cold by is a Otc medication manufactured, distributed, or labeled by HBC Pharma LLC, GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVALGINA PEDIATRICO COUGH AND COLD  PEDIATRICO
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83057-0002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 1 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	88 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83057-0002-2	1 in 1 CARTON	02/01/2023
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2023

Labeler - HBC Pharma LLC (063580631)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	manufacture(83057-0002)