Giltuss Cough And Cold Tablet
FDA Label NDC 58552-331

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 58552-331). 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 - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Otc - Purpose

Purposes

Antitussive

Expectorant

Nasal Decongestant

Indications & Usage

Uses

Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Warnings

Warnings

Otc - Do Not Use

Do not use more than the recommended dosage

  • or if you are 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Otc - Ask Doctor

Ask a doctor before use if you have:

  • heart disease
  • excessive phlegm (mucus)
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur

    • These could 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 the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

• Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period.

• Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period.

• Children under 6 years of age: Consult a physician.

Inactive Ingredient

Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Otc - Questions

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

Package Label.Principal Display Panel

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS
SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

  • COUGH AND COLD
  • CHEST CONGESTION
  • LOOSENS PHLEGM AND MUCUS
  • STUFFY NOSE
  • NASAL CONGESTION
  • SINUS PRESSURE

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