Giltuss Hbp Cough And Chest Congestion Solution
FDA Label NDC 58552-132

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss Hbp Cough And Chest Congestion (NDC 58552-132). 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 other, otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin, 200 mg

Otc - Purpose

Purposes

Cough Suppressant

Expectorant

Indications & Usage

Uses

  • temporarily relieves
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Otc - Do Not Use

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 doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

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 or professional help or contact a Poison Control Center immediately.

Otc - Questions

Questions or comments?

Call 1-787-848-9114, Monday - Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Package Label.Principal Display Panel

MAXIMUM STRENGTH

HBP GILTUSS®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

ALCOHOL FREE. NON-DROWSY

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LIQUIFIES AND LOOSENS PHLEGM AND MUCUS
  • RASPBERRY FLAVOR

    4FL OZ (118 mL)

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