Label: PRESGEN B- dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup

  • 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 October 31, 2019

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp)

    Brompheniramine Maleate, 4 mg
    Dextromethorphan HBr, 20 mg
    Phenylephrine HCl, 10 mg

  • PURPOSE

    Purposes

    Antihistamine
    Cough Suppressant
    Nasal Decongestant

  • INDICATIONS & USAGE

    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

    Warnings: Do not use

    • in a child under 2 years of age
    • if you are 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 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) • trouble urinating due to an enlarged prostate gland • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. Do not give this product to children who have breathing problems such as chronic bronchitis or who have glaucoma without first consulting child's doctor.

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    While using this product:
    • do not exceed recommended dosage • excitability may occur especially in children • drowsiness may occur; alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

    Stop use and ask a doctor if:
    • you get nervous, dizzy or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

    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

  • DOSAGE & ADMINISTRATION

    Directions do not take more than 6 doses in any 24-hour period

    EVERY 4 HOURS  Adults and Children 12 years of age and over                    5mL (1 tsp)
     Children 6 years to under 12 years                                  2. 5 mL (1/2 tsp)
     Children under 6 years                                                    consult physician
     Children under 2 years                                                     do not use

  • STORAGE AND HANDLING

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

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, flavor, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water and sucralose

  • SPL UNCLASSIFIED SECTION

    Compare to Tussi- Pres B®

    Brompheniramine Maleate
    ANTIHISTAMINE

    Dextromethorphan HBr
    COUGH SUPPRESSANT

    Phenylephrine HCl
    NASAL DECONGESTANT

    SUGAR AND ALCOHOL FREE
    SACCHARINE FREE
    DYE FREE

    GRAPE FLAVOR

    Manufactured in the USA for Kramer Novis. San Juan, Puerto Rico 00917 Tel.787-767-2072 www.kramernovis.com

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    PRESGEN B  
    dextromethorphan hydrobromide, brompheniramine maleate, phenylephrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-637
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (SWEET GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-637-16480 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)