Label: HELP I HAVE A STUFFY NOSE- phenylephrine tablet

  • Category: HUMAN OTC DRUG LABEL

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 9, 2012

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  • ACTIVE INGREDIENT

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

    Phenylephrine HCl (5 mg)............................Nasal Decongestant

  • PURPOSE


    Uses
     Temporarily relieves nasal congestion due to:
    • the common cold
    • hay fever or other upper respiratory allergies
    • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
  • WARNINGS



    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 the MAOI drug. If you do not know i your prescription drug contains an
    MAOI, ask a doctor of pharmacist before taking this product.

    Ask a doctor before use if you have
    • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to
    an enlarged prostate gland.

    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.

  • DO NOT USE

    When using this product do not use more than directed

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chidlren.

    In case of accidental oversode, contact a doctor or Poison Control Center immediately.

  • PREGNANCY OR BREAST FEEDING


    If pregnant or breast feeding, ask a health professional before use.
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and over: 2 tablets (10 mg) every 4 hours. • do not exceed 12 tablets (60 mg) in 24 hours

    • children under 12 years of age: Consult a doctor

  • INDICATIONS & USAGE



    Other Information
    • store at room temperature 15-30 degrees C (59-86 degrees F) in a dry place • do not use if blister package is torn.• keep container. They contain important information.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    microcrystalline cellulose, magnesium stearate, silicon dioxide, dicalcium phosphate, starch, stearic acid, croscarmellose sodium

  • QUESTIONS



    Distributed by Help Remedies,

    57 W. 28th St. Fl. 4
     
    New York, NY 10001

    www.helpineedhelp.com
  • PRINCIPAL DISPLAY PANEL

    stuffylabel

  • INGREDIENTS AND APPEARANCE
    HELP I HAVE A STUFFY NOSE 
    phenylephrine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-716
    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)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round tablet) Size7mm
    FlavorImprint Code FR4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49260-716-5050 in 1 BOTTLE
    2NDC:49260-716-1616 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2012
    Labeler - Help Remedies, Inc. (050359682)
    Registrant - Help Remedies, Inc. (050359682)
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