Broncochem Syrup
FDA Label NDC 65131-180

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Magnachem International Srl for the product Broncochem (NDC 65131-180). 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 warnings, uses, active ingredients, ask a doctor before use if your kid have, stop use and ask a doctor if, keep out of the reach od children, overdose warnigs, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

Do not Use

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product.

Uses

Temporarily relieves coug due to minor throat and Bronchial irritation occurring with common cold.  Helps loosen phlegm (mucus) and dilute bronchial secretions to make cough more productive.

Active Ingredients

Guaifenesin........................100.00mg

Dextromethorphan HBr........10.00mg

Ask A Doctor Before Use If Your Kid Have

Cough that occurs with too much phlegm (mucus)

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to any other component of this formula

Stop Use And Ask A Doctor If

Symptoms last more than 5 days

Cough occurs with fever, rash or persistent headache, this could be signs of a serious condition

Keep Out Of The Reach Od Children

Keep out of the reach of children

Overdose Warnigs

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Directions

Take only as directed, for your convinience a dosage spoon is provided. Do not excees 4 doses in a 24 hour period

Children from 6 to 12 years------15mL or cc every 6 hours

Children from 2 to 6 years-------7.5mL or ccevery 6 hours

Children under 2 years, ask your doctor

Other Information

Store al 66-77

Inactive Ingredients

Propylene glycol, Glycerin, Sorbitol 70%, Povidone, Sodium Citrate Dihydrate, Sodium Chloride,

Green color, White Vanilla Flavor, Aloe Vera, Methy Paraben USP, Propil Paraben USP. Peppermint Flavor, Bubble  Gum Flavor, Purified Water

Quiestions

1-561-338-5221 or visit us at www.broncochem.com

Purpose

Guaifenesin........................Expectorant

Dextromethorphan HBr.........Antotussive

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