FDA Label for Giltuss Cough And Cold
View Indications, Usage & Precautions
Giltuss Cough And Cold Product Label
The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Other information
- Store at room temperature, USP
- Do not use if blister seal is broken
MANUFACTURED FOR GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
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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