BIO-RYTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]

BIO-RYTUSS (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-250-16
Set ID e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp.)                 Purpose

    Chlorpheniramine Maleate   2 mg                                  Antihistamine

    Dextromethorphan Hydrobromide 10 mg                        Cough Suppressant

    Phenylephrine Hydrochloride        5 mg                         Nasal Decongestant


  • PURPOSE

    Purpose

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • WARNINGS

    Warnings

    Ask doctor before use if you have

    • Cough that occurs with too much phlegm (mucus), or a breathing problem or persitent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.
    • Heart disease
    • High blood pressure
    • Thyroid Disease
    • Diabetes
    • Difficulty in urinating due to enlarged prostate gland
    • Glaucoma

    Ask doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant; taking sedatives or tranquilizers.

    When using this product

    • Do not use more than directed
    • May cause marked drowsiness; avoid alcohol beverages; alcohol, sedatives and tranquilizers may increase drowsiness. 
    • Be careful when driving a motor vehicle or operating machinery; excitability may occur, especially with children.
  • DO NOT USE

    Do not use

    • To sedate a child or to make a child sleepy
    • If you are now 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 you are taking a prescription that contains an MAOI, ask your doctor or pharmacist before taking this product
    Stop use and ask a doctor if you
    • you get 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 headaches. These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a doctor before use

  • DOSAGE & ADMINISTRATION

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

    adults and children
    12 years of age
    2 teaspoonful (10 mL)
    every 4-6 hours
    children 6 to under
    12 years of age
    1 teaspoonful (5 mL)
    every 4-6 hours
    children 2 to under 6 years of age

    1/2 teaspoonful (2.5 mL)

    every 4-6 hours

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis); runny nose; sneezing; itchy watery eyes; itching of the nose or throat
    • temporarily restores freer beathing through the nose.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Citric acid, FD&C Red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, Sodium citrate, sucralose.

  • QUESTIONS

    Questions or comments?

    1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    rytusslabel

  • INGREDIENTS AND APPEARANCE
    BIO-RYTUSS 
    chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-250
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (cherry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-250-16473 mL in 1 BOTTLE; 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 - Advanced Generic Corporation (831762971)