SUPRESS DX PEDIATRIC DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]

SUPRESS DX PEDIATRIC DROPS (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]
PDF | XML

NDC 52083-055-01
Set ID ddb95436-7806-4086-af4d-18a6625b5c83
Category HUMAN OTC DRUG LABEL
Packager KRAMER NOVIS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredients (in each 1mL)

    Dextromethorphan HBr, 5mg

    Guaifenesin, 50mg

    Phenylephrine HCl, 2.5mg

  • Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • temporarily relieves:
      • nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
      • cough due to minor throat and bronchial irritation as may occur with the common cold
  • 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 giving this product.

    Ask a doctor before use if the child has
    • heart disease • thyroid disease • high blood pressure
    • diabetes
    • 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 recommended dosage.

    Stop use and ask a doctor if
    • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

  • Directions

    • do not use more than 6 doses in any 24 hour period.
    • repeat every 4 hours.
    • measure with the dosage device provided. Do not use with any other device.
    • children 2 to under 6 years of age, 1 mL.
    • children under 2 years of age, consult a doctor.
  • Other information

    • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.
    • Store at controlled room temperature 15-30°C (59-86°F).
    • Avoid excessive heat and humidity.
  • Inactive Ingredients

    citric Acid, FD&C red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

  • SPL UNCLASSIFIED SECTION

    COUGH SUPPRESSANT

    EXPECTORANT

    NASAL DECONGESTANT

    NO SUGAR ALCOHOL

    Manufactured in the USA for Kramer-Novis

    San Juan, PR 00917 • Tel: (787) 767-2072

  • Packaging

    SupresDX

  • INGREDIENTS AND APPEARANCE
    SUPRESS DX PEDIATRIC DROPS 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-055
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorred (CHERRY RED) Score    
    ShapeSize
    FlavorCHERRY (SOUR CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-055-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/29/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/29/2011
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)