Bronco Silen-dm
FDA Label NDC 59561-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Caribe Natural, Llc for the product Bronco Silen-dm (NDC 59561-202). 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 active ingredients (in each 10ml), purpose, uses, warnings, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 10Ml)

Dextromethorphan HBr 20 mg
Guaifenesin 400 mg

Purpose

Cough Suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use if you are now taking a 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 prescription drug contains an MAOI, ask a health professional before taking this product.

Ask A Doctor Before Use If You Have

  • cough that occurs with to much phlegm (mucus)
  • cough that last or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Other Information

  • Store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

Cherry Flavor, Citric Acid, FD&C red no. 40, Hydroxyethyl Cellulose, Menthol, Methylparaben, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and Sucralose

Questions:

Contact us Monday to Friday at (305) 256-1469 9:00am - 5:00pm EST.

Display Label

NDC 59561-202-04
GERMA
BRONCO-SILEN-DM
COUGH SUPPRESSANT
EXPECTORANT
Sugar FREE
Alcohol FREE
Non-Drowsy
New Improved Taste
Stronger than Leading Brands
Contents: 4 FL. OZ. (118 mL)

Bronco Silen-dm (Bronco Silen Dm)

Bronco Silen-dm (Bronco Silen Dm)

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