Giltuss Ex Maximum Strength Expectorant Tablet
FDA Label NDC 58552-341

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 Maximum Strength Expectorant (NDC 58552-341). 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 drug facts, active ingredient purpose (in each extended-release bi-layer tablet), uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient Purpose (In Each Extended-Release Bi-Layer Tablet)

Guaifenesin, 1200 mg....................................................................Expectorant

Uses

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

Warnings

  • Do not use for children under 12 years

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness.

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 right away (1-800-222-1222).

Directions

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours
  • Do not exceed 2 tablets in 24 hours
  • Do not use for children under 12 years of age

Other Information

  • Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing
  • Store between 20°-25°C (68°-77°F)
  • Tamper evident: Do not use if carton is open or if printed seal under cap is broken or missing.

Inactive Ingredient

Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch  glycolate.

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.

revised: 08/25

Principal Display Panel

GILTUSS EX MAXIMUM STRENGTH EXPECTORANT / EXPECTORANTE (Guaifenesin, 1200 mg) - NDC 58552-341-14 - 14 Tabs Bottle label

Image Description (Glituss Ex Max Expectorant Tabs 600mg 20s Bottle Label)

Image Description (Glituss Ex Max Expectorant Tabs 600mg 20s Bottle Label)

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