Label: TUSSI PRES PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup

  • NDC Code(s): 52083-232-01, 52083-232-04, 52083-232-05, 52083-232-16
  • Packager: KRAMER NOVIS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 6, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (In each 5 mL teaspoon)

    Dextromethorphan HBr 5 mg

    Guaifenesin 75 mg

    Phenylephrine HCl 2.5 mg

  • Purpose

    Antitussive (Anti-Cough)

    Expectorant

    Nasal Decongestant

  • Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. 

    • Temporarily relieves these symptoms occurring with a cold: nasal congestion and cough due to minor throat and bronchial irritation.

  • Warnings:

    Do not use: • in a child under 2 years of age. • 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:

    • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.

    Do not use more than the recommended dose.

    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.

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

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

  • Directions:

    Do not take more than 6 doses in any 24-hour period.

     Adults & Children 12 years of age and older Take 4 teaspoons (20 mL) every 4 hours, as needed.
     Children 6 to under 12 years of age Take 2 teaspoons (10 mL) every 4 hours, as needed.
     Children 2 to under 6 Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.
     Children under 2 years Do not use.

  • Other Information:

    • Tamper Evident. Do not use if packet is torn, cut or opened.

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

    • Avoid excessive heat or humidity.

  • Inactive Ingredients:

    Citric acid, Flavor, Glycerin, Methylparaben, Propylene glycol, Propylparaben, Purified water, Sodium citrate and Sucralose

  • SPL UNCLASSIFIED SECTION

    COUGH SUPPRESSANT, EXPECTORANT, NASAL DECONGESTANT

    SUGAR, ALCOHOL, SACCHARIN, SORBITOL & DYE FREE

    ORANGE FLAVOR

    Manufactured in the USA for: Kramer Novis, San Juan, PR 00917.

    1 (787) 767-2072 www.kramernovis.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    TUSSI PRES PEDIATRIC 
    guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-232
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGE (CITRUS ORANGE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-232-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/201107/12/2017
    2NDC:52083-232-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/201107/12/2017
    3NDC:52083-232-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/24/2011
    4NDC:52083-232-055 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/24/2011
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)