VASOPRO EPHEDRINE (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [OPTIMAL RESEARCH INC]

VASOPRO EPHEDRINE (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [OPTIMAL RESEARCH INC]
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NDC 70258-320-24
Set ID 750f9a39-acdc-4abc-800e-467884a4dcea
Category HUMAN OTC DRUG LABEL
Packager Optimal Research Inc
Generic Name
Product Class alpha-Adrenergic Agonist, beta-Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredients (in each tablet)

    Ephedrine Hydrochloride 25mg

    Guaifenesin 200mg

  • Purpose

    Bronchodilator

    Expectorant

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Uses: Temporarily relieves shortness of breath, tightness of chest, and wheezing due to bronchial asthma 

    Eases breathing for asthma patients  Helps loosen mucus and thin bronchial secretions to drain bronchial tubes.

  • Warnings:

    Do not use this product • unless a diagnosis of asthma has been made by a doctor
    If seal is not intact or punctured.

    Ask a doctor before use if you have
    heart disease high blood pressure  thyroid disease  diabetes
    difficulty in urination due to enlargement of the prostate gland.

    Ask a doctor before use if you have been hospitalized for asthma

    you are taking any prescription drug for asthma.

    Stop use and ask a doctor if symptoms do not get better within 1 hour or become worse

    you get nervous or sleepless, have tremors or nausea, or lose your appetite

    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.

    Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma,

    chronic bronchitis, or emphysema cough with excessive mucus

    If pregnant or breast-feeding, ask a health care professional before use.

    Do not use if you are taking any 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 don’t know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Directions:

    Adults and children 12 years of age and over. Take 1 tablet every 4 hours: do not take more than 6 tablets in 24 hours

    Children under 12 years of age: Consult a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Colloidal silicon dioxide, Croscarmellose sodium, Magnesium stearate, Maltodextrin, Microcrystalline cellulose

    Povidone, Pregelatinized corn starch, Stearic acid.

  • SPL UNCLASSIFIED SECTION

    Tamper evident, do not use if blister seals are not intact
    Maximum Sale Allowed 2 Boxes Per Transaction

    MEGA-PRO®
    INTERNATIONAL

    Maximum Strength
    VASOPRO
    EPHEDRINE
    Expectorant / Bronchodilator
    24 Tablets


    DO NOT SELL TO MINORS
    ABUSE OF THIS PRODUCT COULD BE FATAL

    Distribution of this product requires a DEA License.

    Distributed by: Mega-Pro International®, St. George, UT 84770

  • Packaging

    VASOPRO

  • INGREDIENTS AND APPEARANCE
    VASOPRO EPHEDRINE 
    ephedrine hydrochloride, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70258-320
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE25 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore4 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code MP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70258-320-241 in 1 BOX11/23/2015
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/23/2015
    Labeler - Optimal Research Inc (612492678)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmatech Llc968082094manufacture(70258-320)

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