SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]

SUPRESS A (DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [KRAMER NOVIS]
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NDC 52083-057-01
Set ID f0bec5f5-4d76-471e-9024-557eba848b93
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredients (in each 1 mL)

    Dexbrompheniramine Maleate, 1 mg

    Dextromethorphan HBr, 10 mg

    Phenylephiren HCl, 5 mg

  • Purpose

    Antihistamine

    Cough suppressant

    Expectorant

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy nose or throat
    • runny nose
    • itchy, watery eyes
    • nasal congestion
    • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
    • temporarily restores freer breathing through nose
  • 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 you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
    • Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
    When using this product
    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • may cause marked drowsiness
    • sedative and tranquilizers may increase drowsiness effect
  • STOP USE

    Stop use and ask a doctor if

    • nervousness dizziness, or sleeplessness occur
    • new symptoms occur
    • symptoms do not improve 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.

  • PREGNANCY OR BREAST FEEDING

    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.
    • measure with the dosage device provided. Do not use any other device
  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
    • Store at controlled room temperature 15°-30°C (59° to 86°F).
    • Avoid excessive heat and humidity.
  • Inactive ingredients

    Citric acid, flavor, glycerin, methylparaben, polysorbate, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.

  • SPL UNCLASSIFIED SECTION

    Made in the USA for Kramer Novis.

    San Juan, PR 00917

    (787) 767-2072 / www.kramernovis.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUPRESS A 
    dexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg  in 1 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-057-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2012
    Labeler - Kramer Novis (090158395)
    Registrant - KRAMER NOVIS (090158395)