Label: BIO-RYTUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

  • NDC Code(s): 45737-250-16
  • Packager: Advanced Generic Corporation
  • 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 23, 2020

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  • 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)
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