FDA Label for Phenylephrine
View Indications, Usage & Precautions
Phenylephrine Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors 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.
Active Ingredient
Phenylephrine hydrochloride 10 mg
Purpose
Nasal decongestant
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Uses
° temporarily relieves sinus congestion and pressure
° temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings
Do not use if you are now taking a prescription monoamine exidase 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.
Ask a doctor before use if you have:
° heart disease ° high blood pressure ° diabetes ° trouble urinating due to an enlarge prostate gland ° thyroid disease
When using this product, do not use more than directed.
Stop use and ask a doctor if:
° you get nervous, dizzy or sleepless
° symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding, ask a health professional before use.
Directions
° take every 4 hours
° do not take more than 6 doses in 24 hours
° adults and children 12 years of age and over: 1 tablet
° children under 12 years of age: ask a doctor
Other Information
Store at room temperature (59°-86°F)
Inactive Ingredients
carnauba wax. dibasic calcium phosphate, FD&C red no. 40, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
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