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 January 31, 2022

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  • Active ingredients (in each caplet)

    Guaifenesin 400mg

    Phenylephrine HCl 10mg

  • Purpose

    Expectorant

    Nasal decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
    • helps to make cough more productive
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • promotes nasal and/or sinus drainage
    • temporarily relieves sinus congestion and pressure
  • 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 if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to an enlarged prostate gland
    • cough accompanied by too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days, or are accompanied by a fever
    • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache

    These could be sings 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 the meals
    • do not exceed 6 doses in 24 hours or as directed by a 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

    ask a doctor

  • Other information

    store at 20 0- 25 0C (68 0-77 0F)

  • 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 or comments?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    ULAI HEALTH LLC.

    Alexandria, VA 22312

  • PRINCIPAL DISPLAY PANEL

    PHARBEST 

    NDC 73057-389-04

    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:73057-389
    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) PHENYLEPHRINE HYDROCHLORIDE10 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 K30 (UNII: U725QWY32X)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize19mm
    FlavorImprint Code PH043
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-389-0430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/18/2019
    Labeler - Ulai Health LLC (081181535)
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