SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]

SUPRESS-PE PEDIATRIC (GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]
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NDC 52083-056-01
Set ID a474171d-5c29-4a80-9d37-00613796211a
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 1 mL)

    Guaifenesin, 50 mg

    Phenylephrine HCl, 2.5 mg

  • Purpose

    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 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 a 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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a 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

     age dose
     children 2 years to under 6 years of age 1 mL
     children under 2 years of ageConsult 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, glycerin, grape flavor, methylparaben, polyethylene glycol, purified water, propylene glycol, propylparaben, sodium citrate, sucralose and sucrose.

  • SPL UNCLASSIFIED SECTION

    SUPRESS-PE

    PEDIATRIC DROPS

    EXPECTORANT

    NASAL-DECONGESTANT

    Great Grape Flavor

    DYE FREE

    ALCOHOL FREE

    SACCHARINE FREE

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

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    SUPRESS-PE  PEDIATRIC
    guiafenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-056
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-056-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/14/2014
    Labeler - Kramer Novis (090158395)