MUCUS RELIEF PE (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]

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  • MUCUS RELIEF PE (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]

MUCUS RELIEF PE (GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]
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NDC 68016-686-50
Set ID 31842dc3-1f99-405a-8496-2946a0c3817a
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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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 you have

    • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • 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

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Premier
    Value®

    NDC 68016-686-50

    Mucus Relief PE
    Sinus Congestion

    Guaifenesin 400 mg
    EXPECTORANT
    Phenylephrine HCl 10 mg
    NASAL DECONGESTANT

    Clears nasal/sinus congestion

    Thins and loosens mucus

    Immediate-release

    50 Tablets

    Easy to Swallow

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

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

    50844       ORG061254215

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM, LLC
    UPARC, BLDG. A3, SUITE 338
    1020 WILLIAM PITT WAY
    PITTSBURGH, PA 15238
    www.chaindrugconsortium.com

    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    Premier Value 44-542

    Premier Value 44-542

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF PE 
    guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-686
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    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:68016-686-501 in 1 CARTON04/15/2006
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/15/2006
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(68016-686)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(68016-686)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(68016-686)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(68016-686)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(68016-686)
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