MUCUS RELIEF D IMMEDIATE RELEASE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]

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MUCUS RELIEF D IMMEDIATE RELEASE (GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET [ALLEGIANT HEALTH]
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NDC 69168-354-07
Set ID 0b2a2dac-7e5c-411b-bedb-87141a11d93d
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredient

    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Expectorant
    Nasal decongestant

  • Uses

    helps loosen phlegm (mucus) and helps thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies 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 trouble urinating due to an enlarged prostate gland■ cough accompanied by excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

    When using this product

    ■ do not use more than directed

    Stop use and ask a doctor if

    you get nervous, dizzy, or sleepless
    cough lasts for more than 7 days, recurs, or is accompanied by 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 accidental 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 doses in 24 hours.

    Children under 12 years of age: do not use

  • Other Information

    store at 25° C (77° F) excursions between 15°-30° C (59°-86° F)do not use if imprinted safety seal under cap is broken or missing You may report side effects to 1-888-952-0050

  • Inactive Ingredients

    colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Mucus Relif D\LB1097.jpg
  • INGREDIENTS AND APPEARANCE
    MUCUS RELIEF D  IMMEDIATE RELEASE
    guaifenesin and phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-354
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code AZ354
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-354-0710 in 1 CARTON; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/23/2014
    Labeler - Allegiant Health (079501930)
    Registrant - Allegiant Health (079501930)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930ANALYSIS(69168-354) , LABEL(69168-354) , MANUFACTURE(69168-354) , PACK(69168-354) , RELABEL(69168-354) , REPACK(69168-354)
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