Giltuss Cough And Cold Solution
FDA Label NDC 58552-130

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 Cough And Cold (NDC 58552-130). 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 - ask doctor/pharmacist, 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 5 mL)

Dextromethorphan HBr, 15 mg

Guaifenesin, 300 mg

Phenylephrine HCI, 10 mg

Otc - Purpose

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily relieves nasal congestion due to a cold

Otc - Do Not Use

Do not use if you are 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

  • heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache
  • These can 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 accident 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

GILTUSS®

COUGH & COLD

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS
  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE
  • 4 FL OZ (118 mL)

    58552-130 (58552 130)

    58552-130 (58552 130)

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