Giltuss Ex Expectorant Solution
FDA Label NDC 58552-145

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 Ex Expectorant (NDC 58552-145). 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, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 10 mL)

Guaifenesin, 400 mg

Otc - Purpose

Purpose

Expectorant

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings

Otc - Ask Doctor

Ask a doctor before use if you have

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

Otc - Stop Use

Stop use and ask a doctor if cough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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 take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over10 mL every 4 hours
    children 6 to under 12 years of age5 mL every 4 hours
    children 4 to under 6 years of age2.5 mL every 4 hours
    children under 4 years of ageConsult a doctor

Storage And Handling

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredient

Inactive ingredients citric acid, glycerin, methylparaben. natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

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

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

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