Active Ingredient
Phenylephrine hydrochloride 10 mg
Phenylephrine
FDA Label NDC 21695-524
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Phenylephrine (NDC 21695-524). 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 active ingredient, purpose, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package/Label Principal Display Panel
Phenylephrine 10mg (C40df8f6 8374 4f9b Bfce 94d582470d48 01)
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