Label: MUCUS RELIEF SINUS- guaifenesin and phenylephrine hcl tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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  • Active ingredients (in each immediate-release tablet)

    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Expectorant
    Nasal decongestant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs 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

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

    When using this product

    do not exceed recommended dosage.

    Stop use and ask a doctor if

    •
    you get nervous, dizzy or sleepless
    •
    cough comes back or worsens
    •
    symptoms do not improve within 7 days, come back or occur with fever, rash or persistent headache. These could be signs of a serious condition.

    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 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours.
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    •
    see end flap for expiration date and lot number 
  • Inactive ingredients

    hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Principal Display Panel

    NDC 63187-587-30

    Mucus Relief
    Sinus

    Guaifenesin 400 mg /
    Phenylephrine HCl 10 mg

    Expectorant / Nasal Decongestant

    •
    Alleviates Chest Congestion
    •
    Relieves Nasal/Sinus Congestion
    •
    Does Not Contain Pseudoephedrine

    30 Tablets

    Immediate
    Release

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

    50844        REV0612D54201
    Distributed by Major Pharmaceuticals
    31778 Enterprise Drive, Livonia, MI 48150 USA

    Relabeled by Proficient Rx LP
    Thousand Oaks, CA 91320


    Rev. 12/14    M-17      Re-order No. 006474

    63187-587-30

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF SINUS 
    guaifenesin and phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-587(NDC:0904-5792)
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code 44;542
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-587-301 in 1 CARTON12/01/2015
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:63187-587-601 in 1 CARTON12/01/2015
    260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/15/2006
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-587) , RELABEL(63187-587)
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