MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]

MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]
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NDC 41250-547-72
Set ID 383281d7-0d25-4423-ace2-d2985f2c37d0
Category HUMAN OTC DRUG LABEL
Packager Meijer Distribution Inc
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each immediate-release tablet)

    Guaifenesin 400 mg
    Pseudoephedrine HCl 40 mg

  • Purpose

    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • promotes nasal and/or sinus drainage
    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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

    • cough accompanied by too much phlegm (mucus)
    • heart disease
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure
    • diabetes
    • 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 occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs or 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 (1-800-222-1222) right away.

  • Directions

    • adults and children 12 years and over: 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: do not use
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • 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 of comments?

    1-800-426-9391

  • Principal Display Panel

    NDC 41250-547-72

    meijer®

    mucus relief D
    Guaifenesin | Pseudoephedrine HCl
    Expectorant | Nasal Decongestant

    27 Tablets     actual size

    Clears Nasal/
    Sinus Congestion
    Thins & Loosens Mucus

    Immediate Release

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    50844       REV0419A54772

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

    Meijer 44-547

    Meijer 44-547

  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF D 
    guaifenesin, pseudoephedrine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-547
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE40 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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize16mm
    FlavorImprint Code 44;547
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-547-723 in 1 CARTON01/26/2007
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/26/2007
    Labeler - Meijer Distribution Inc (006959555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(41250-547)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(41250-547)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(41250-547)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(41250-547)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(41250-547)

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