Label: NASAL AND SINUS DECONGESTANT- phenylephrine hydrochloride 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 September 19, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In Each Tablets)

    Phenylephrine HCl 5 mg

  • Purpose

    nasal decongestant

  • Use

    temporarily relieves nasal congestion due to:

    • common cold
    • hay fever or other upper respiratory allergies
  • Warnings

    Do not use 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 an MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product do not exceed recommended dose

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • new symptoms occur

    If pregnant or breast-feeding ask a health professional before use.

    Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and older take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
    • Children under 12 years of age: ask a doctor
  • Other Information

    • do not use if packet is opened or torn
    • store at room temperature, 59° - 86°F (15° - 30°C)
    • avoid excessive heat and humidity
  • Inactive Ingredients

    croscarmellose sodium, D&C Red #27, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, stearic acid

  • Questions?

    1-866-651-3660 Monday-Friday

    8:00am-5:00pm EST

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Box

    Product #1262

    Nasal & Sinus
    Decongestant II

    Nasal Decongestant

    Active ingredient:
    Phenylephrine

    • Helps reduce nasal and sinus congestion and
      pressure, and helps restore free breathing
      through the nose

    These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    100 Tablets • 2 Tablets Per Packet

    PRINCIPAL DISPLAY PANEL - 100 Tablet Box
  • PRINCIPAL DISPLAY PANEL - 250 Tablet Box

    Product #1264

    Nasal & Sinus
    Decongestant II

    Nasal Decongestant

    Active ingredient:
    Phenylephrine

    • Helps reduce nasal and sinus congestion and
      pressure, and helps restore free breathing
      through the nose

    These quality comfort tablets are formulated and packaged for use in the
    workplace and meet ANSI Z308.1-2015 standards. They are sealed in
    tamper-evident packets for safety and convenience.

    250 Tablets • 2 Tablets Per Packet

    PRINCIPAL DISPLAY PANEL - 250 Tablet Box
  • INGREDIENTS AND APPEARANCE
    NASAL AND SINUS DECONGESTANT 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1262
    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. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1262-150 in 1 BOX02/02/2000
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/02/2000
    NASAL AND SINUS DECONGESTANT 
    phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-1264
    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. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code 271
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73598-1264-1125 in 1 BOX02/02/2000
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/02/2000
    Labeler - JHK Inc dba American Safety & First Aid (867236309)
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