Label: PHARBINEX-PE- guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated

  • 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 May 1, 2018

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  • Active ingredients (in each caplet)

    Guaifenesin 400mg

    Phenylephrine HCl 10mg

  • Purpose

    Expectorant

    Nasal Decongestant

  • Uses

    Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies

    • helps loosen phlegm(mucus)
    • thin bronchial secretions
    • drain bronchial tubes
    • make coughs more productive
    • loosen nasal congestion
    • clear stuffy nose
    • clear nasal passageways
    • shrinks swollen membranes
  • Warnings

    Do not exceed recommended dosage.

    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 MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask your doctor or pharmacist before using this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • excessive phlegm (mucus)
    • difficulty in urination due to enlargement of prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • symptoms are accompanied by fever, rash or persistent headache
    • cough and congestion do not improve within 7 days or tend to recur

    These could be signs of a serious illness.

    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 (1-800-222-1222).

    Directions

    • take with a full glass of water
    • this product can be administered without regard for the timing of meals
    • do not exceed 6 doses in 24 hours or as directed by doctor

    adults and children 12 years of age and over

    take 1 caplet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ caplet every 4 hours as needed

    children under 6 years of age

    consult a doctor

  • Other information

    • store at room temperature (15°-30°C)
  • Inactive ingredients

    croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

  • Questions?

    Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    PHARBEST 

    NDC 16103-0389-04

    Manufactured in the USA

    Immediate Release

    PHARBINEX-PE

    Guaifenesin 400mg & Phenylephrine HCl 10mg

    Expectorant & Nasal Decongestant

    30 CAPLETS

    Pharbinex PE Caplet Product Label Image

  • INGREDIENTS AND APPEARANCE
    PHARBINEX-PE 
    guaifenesin 400mg and phenylephrine hcl 10mg tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-389
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULE (CAPSULE SHAPED TABLET) Size19mm
    FlavorImprint Code PH043
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-389-041 in 1 CARTON05/01/2018
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2018
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-389) , analysis(16103-389) , pack(16103-389) , label(16103-389)
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