SUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]

SUPRESS DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SYRUP [KRAMER NOVIS]
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NDC 52083-058-01
Set ID 7da0611e-729c-4cf8-88f3-f8877b9f5cfa
Category HUMAN OTC DRUG LABEL
Packager KRAMER NOVIS
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredients (in each 1 ml)

    Dextromethorphan HBr, 5 mg

    Guaifenesin, 50 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • Uses

    • Temporarily controls cough due to minor throat and bronchial irritation as may occur with a cold
    • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive.

  • Warnings

    Do not use:

    in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if your child has

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with asthma.

    When using this product do not exceed the recommended dosage.

    Stop use and ask a doctor if

    • new symptoms occur
    • coughs persists for more than 1 week, tends to recur, 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

    Children 6 to under 12 years of age

    • 1 mL every 4 hours as needed, do not exceed 6 doses in any 24-hour, or as directed by a doctor

    • Children under 6, consult a doctor

  • Inactive ingredients

    Citric acid, flavor, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

  • Other information

    • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

    • Store at controlled room temperature 15°-30°C (59°-86°F).

    • Avoid excessive heat and humidity.

  • SPL UNCLASSIFIED SECTION

    COUGH SUPRESSANT

    EXPECTORANT

    No sugar, dye, alcohol, aspartame or sorbitol

    DECONGESTANT FREE

    Manufacture in the USA for Kramer-Novis, San Juan, PR 00917. Tel: (787) 767-2072

    www.kramernovis.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SUPRESS DM 
    dextromethorphan hydrobromide, guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 1 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (SWEET CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-058-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/02/2013
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)