Giltuss Childrens Cough And Cold Solution
FDA Label NDC 58552-131

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 Cold (NDC 58552-131). 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 2.5 mL)

Dextromethorphan HBr 7.5 mg

Guaifenesin 150 mg

Phenylephrine HCI 5 mg

Otc - Purpose

Purposes

Cough Suppressant

Expectorant

Nasal decongestant

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive and drain bronchial tubes
  • stuffy nose

Otc - Do Not Use

Do not use

  • to sedate a child or make a child sleepy
  • in a child who is 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 giving this product.

Otc - Ask Doctor

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with asthma or chronic bronchitis

Otc - Stop Use

  • Stop use and ask a doctor if
  • nervousness, dizziness, or sleepless occurs
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts 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 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 & COLD

ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

Alcohol Free. Sugar Free. Dye Free.

  • COUGH AND COLD
  • CHEST CONGESTION
  • STUFFY NOSE
  • NASAL CONGESTION
  • LOOSEN PHLEGM AND MUCUS
  • SINUS PRESSURE
  • CHERRY FLAVOR

    4 FL OZ (118 mL)

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