TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]

TUSSLIN PEDIATRIC (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]
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NDC 52083-623-01
Set ID 6fe91407-08c1-465b-9c00-251c94b1f7f0
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients (in each 1 mL)                    Purpose

    Dextromethorphan HBr, 7.5 mg..............................Antitussive

    Guaifenesin, 88 mg..............................................Expectorant

    Phenylephrine HCl, 2.5 mg................................Nasal decongestant



  • PURPOSE

    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
    • cough due to minor throat and bronchial irritation as may occur with the common cold
  • WARNINGS


    Warnings

    Do not use
    in 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.

  • DO NOT USE


    Ask a doctor before use if your child has
    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • a 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
    • new symptoms occur
    • 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.
  • PREGNANCY OR BREAST FEEDING


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


  • KEEP OUT OF REACH OF CHILDREN


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


  • DOSAGE & ADMINISTRATION


    Directions

    do not use more than 4 doses in any 24-hour period

    Children 6 to under 12 years of age

    • 2 mL every 6 hours, do not exceed 4 doses.

    Children 2 to under 6 years of age

    • 1 mL every 6 hours, do not exceed 4 doses, or as directed by a doctor.

    Children under 2, consult a doctor

    • measure with the dosage device provided. Do not use any other device.
  • INDICATIONS & USAGE


    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.

  • INACTIVE INGREDIENT


    Inactive ingredients
    Citric acid, flavors, menthol, methyl paraben, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, propyl paraben, purified water, sorbitol and sucralose.

  • QUESTIONS

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

  • Principal Display Panel

    TUSSLIN®

    PEDIATRIC DROPS

    Contains the same active ingredients as Glituss® Pediatric

    Antitussive

    Expectorant

    Nasal Decongestant

    Sugar, Alcohol & Dye Free

    NET CONTENT: 30 mL (1 Fl. Oz.)

    KRAMER-NOVIS

    kramer-supress-pe
  • INGREDIENTS AND APPEARANCE
    TUSSLIN  PEDIATRIC
    dextromethorphan hbr, guiafenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-623
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN88 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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-623-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2014
    Labeler - Kramer Novis (090158395)