Breacold Adult
FDA Label NDC 53145-040

9 label sections · Submitted to the FDA by Menper Distributors, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors, Inc. for the product Breacold Adult (NDC 53145-040). 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 tsp), purpose, uses, do not exceed recommended dosage., do not use:, if  pregnant or breast-feeding, directions: do not exceed 6 doses in 24 hours., other information, 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 Tsp)

Guaifenesin 200 mg………………………………Expectorant

Dextromethorphan HBr 20 mg…………………….Cough suppressant

Purpose

Expectorant

Cough Suppressant

Uses

Temporarily relieves cough due to minor throat ands bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Do Not Exceed Recommended Dosage.

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do Not Use:

  • this product for persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • 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 doctor or pharmacist before taking this product.

If  Pregnant Or Breast-Feeding

ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions: Do Not Exceed 6 Doses In 24 Hours.

 Age Dose
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years of age Do not use

Other Information

  • Store this product between 15°-30°C (59°-86°F)

Inactive Ingredients

Citric acid, D&C red #33, glycerin, methylparaben, propylene glycol, propylparaben,raspberry flavor, sucrose, water

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