Guaiasorb Liquid
FDA Label NDC 57896-736

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Guaiasorb (NDC 57896-736). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (per 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Otc - Purpose

Purpose

  • cough suppressant
  • expectorant

Indications & Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm mucus
  • helps thin bronchial secretions to make coughs more productive

Warnings

Warnings

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

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    • Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. 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 overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions 

  • do not exceed recommended dose
  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
    •  Adults and children 12 years and over 2 teaspoonfuls (10 mL)
     Children under 12 years Do not use

Inactive Ingredient

Inactive ingreadients artificial and natural cherry flavor, citric acid, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Package Label.Principal Display Panel

Guaiasorb (Guaiasorb)

Guaiasorb (Guaiasorb)

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