Drug Facts
Active Ingredients (in each tablet)
Dextromethorphan HBr, 28 mg
Guaifenesin, 388 mg
Phenylephrine HCl, 10 mg
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 drug facts, otc - purpose, indications & usage, warnings, otc - do not use, 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.
Active Ingredients (in each tablet)
Dextromethorphan HBr, 28 mg
Guaifenesin, 388 mg
Phenylephrine HCl, 10 mg
Purposes
Antitussive
Expectorant
Nasal Decongestant
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
Do not usemore than the recommended dosage
Ask a doctor before use if you have:
Stop use and ask a doctor if:
These could be signs of a serious condition.
If pregnant or breast-feeding,ask a health professional before use.
Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.
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.
Other information
MANUFACTURED FOR GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Inactive ingredientsCroscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.
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.
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