Label: NASAL AND SINUS DECONGESTANT 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 July 2, 2021

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  • Active Ingredient (in each tablet)........................................................ Purpose

    Phenylephrine HCI 5 mg.......................................................................................................Decongestant

  • Uses:

    Temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus opening and passages ■ restores free breathing

  • Warnings:

    Do not use:

    ■ more than recommended dose ■ 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 MAOI drug. If you do not know if your prescription drug contains a MAOI, consult a doctor or pharmacist before taking this product.

    Stop use and ask a doctor if

    ■ symptoms do not improve ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by fever

  • Ask a doctor before use if you have:

    ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland

  • If pregnant or breast-feeding a baby,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
    Children under 12 years: consult a doctor

  • Other Information:

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

  • Inactive Ingredients:

    corsscarmellose sodium, D&C Red #28, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid

  • PRINCIPAL DISPLAY PANEL

    Decongestant

  • INGREDIENTS AND APPEARANCE
    NASAL AND SINUS DECONGESTANT 
    nasal and sinus decongestant tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code FR4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-333-68100 in 1 CARTON; Type 0: Not a Combination Product10/01/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2017
    Labeler - Redicare LLC (800149346)
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