PSEUDO EPHED PLUS (PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]

PSEUDO EPHED PLUS (PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]
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NDC 65193-325-24
Set ID 848c680c-22c4-4b43-bc3a-21ff72e88888
Category HUMAN OTC DRUG LABEL
Packager Dickey Consumer Products DBA DMD
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient(In Each Tablet): Pseudoephedrine HCl 30 mg, Guaifenesin 200 mg

  • PURPOSE

    Purposes - Nassal Decongestant, Expectorant

  • INDICATIONS & USAGE

    • temporarily relieves nasal congestion due to the common cold • promotes nasal and/or sinus drainage • temporarily relieves sinus congestion and pressure • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • 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 • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • a cough accompanied by excessive phlegm (mucus)

    When using this product • do not use more than directed • intentional abuse of this product can be harmful or fatal

    Stop use and ask a doctor if: • you get nervous dizzy or sleepless • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition. • symptoms do not get better within 7 days or occur with a fever

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health proffessional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • adults and children 12 years of age and over: take 2 tablets every 4 to 6 hours; do not exceed 8 tablets in 24 hours • children under 12 years of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

  • PRINCIPAL DISPLAY PANEL

    Pseudo Ephed Plus 24ct

  • INGREDIENTS AND APPEARANCE
    PSEUDO EPHED PLUS 
    pseudoephedrine hydrochloride, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65193-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (EP230) Size9mm
    FlavorImprint Code EP230
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65193-325-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/15/2019
    Labeler - Dickey Consumer Products DBA DMD (835974056)
    Registrant - Dickey Consumer Products DBA DMD (835974056)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(65193-325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corp.085752004pack(65193-325)

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