Giltuss Childrens Cough And Chest Congestion Solution
FDA Label NDC 58552-133

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 Childrens Cough And Chest Congestion (NDC 58552-133). 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 - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 10 mg

Guaifenesin, 100 mg

Otc - Purpose

Purposes

Cough Suppressant

Expectorant

Indications & Usage

Uses

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

Otc - Do Not Use

Do not use if your child is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Ask Doctor

Ask a doctor before use if the child has

  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma

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.

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

Children's

GILTUSS®

COUGH & CHEST CONGESTION

ANTITUSSIVE AND EXPECTORANT

Non-Drowsy. Alcohol Free

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

    4FL OZ (118 mL)

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