Broncochem Syrup
FDA Label NDC 65131-054

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 65131-054). 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 of children, overdose warning, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

With other drugs containing acetaminophen.

Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

Uses

Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

Active Ingredients

Acetaminophen...................325.00mg

Guaifenesin........................200.00mg

Phenylephrine HCl..................5.00mg

Ask A Doctor Before Use If Your Kid Have

Liver disease

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to acetaminophen or any other componet of this formula

Stop Use And Ask A Doctor If

Symtoms last more than 5 days

Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

If your child is taking the bloood thinning drug warfarin

Keep Out Of The Reach Of Children

Keep out of the reach of children

Overdose Warning

In case of accidental overdose. seek professional assistance or contact a poison control center inmediately

Directions

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

Children from 6 to 12 years-----10mL or cc every 6 hours

Children form 2 to 6 years------5mL or cc every 6 hours

Children under 2 years, ask your doctor

Other Information

store at 66-77*F (20-25*C), do not use if securety cap is altered or broken

Inactive Ingredients

Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

Quiestions?

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

Purose

Acetaminophen...........Analgesic

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

Phenylephrine.............Decongestant

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