Label: PHENYLEPHRINE tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 21, 2011

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  • 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 ...
  • 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 ...
  • Package/Label Principal Display Panel
    Phenylephrine 10mg
  • INGREDIENTS AND APPEARANCE
    Product Information
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