RYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]

RYCONTUSS CHERRY FLAVOR (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [OKENDPHARMA, INC.]
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NDC 76117-001-16
Set ID c91798fa-48ab-47a0-92da-4d44c2aafde0
Category HUMAN OTC DRUG LABEL
Packager Okendpharma, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active ingredients                                                                                       Purpose
    Chlorpheniramine Maleate 2mg............................................................Antihistamine
    Dextromethorphan Hydrobromide 10mg.........................................Cough Supressant
    Phenylephrine Hydrochloride 5mg...............................................Nasal Decongestant

  • PURPOSE

    Uses  - For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever  - Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold  - Temporarily restores freer breathing through the nose

  • WARNINGS

    Warnings  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, psyquiatric or emotional condition, or for 2 weeks after stopping the MAOI drug. - If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

    Ask a doctor before use if you have  - Heart disease.  - Thyroid disease.  - Trouble urinating due to enlarged prostate gland.  - Glaucoma.  - Cough that occurs with too much phlegm (mucus).  - Breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema.

  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product  - Do not use more than directed.  - May cause marked drowsiness.  - Avoid alcoholic beverages.  - Alcohol, sedatives and tranquilizers may cause increased drowsiness.  - Be careful when driving a motor vehicle or operating machinery.  - Excitability may occur, especially with children.

  • STOP USE

    Stop use and ask a doctor if  - You get nervous, dizzy, or sleepless.  - Cough lasts more than 7 days, come back, or is accompanied by a fever, rash, or persistent headaches. 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

    Keep out of reach of children.

  • INDICATIONS & USAGE

    In case of overdose, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION


    Adults and children 12 or older
    2 tsp (10 mL) every 4 hours
    Chidren age 6 - 12
    1 tsp (5 mL) every 4 hours
    Children younger than 6
    Ask a doctor

  • STORAGE AND HANDLING

    Other information  - Store at controlled room temperature between 15-30 C (58-86F)  - Avoid excessive heat or humidity.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Citric acid, DandC red #33, FDandC red #40, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucrose.

  • QUESTIONS

    Questions or comments  Phone: 1-787-548-0016, Labor hours 8:00 am to 5:00 pm

  • DESCRIPTION

    Manufactured for:  Okendpharma Inc,  4287 Constancia Ave. Villa Del Carmen Ponce, PR 00716  United States  Product of Puerto Rico

  • PRINCIPAL DISPLAY PANEL

    NDC  RYCONTUSS Liquid  CHERRY FLAVOR  ANTITUSSIVE NASAL  DECONGESTANT AND ANTIHISTAMINE  16 fl oz (1 print) (473 ml)  Lot #  Exp.Date

  • PRINCIPAL DISPLAY PANEL

    Rycontuss

  • INGREDIENTS AND APPEARANCE
    RYCONTUSS   CHERRY FLAVOR
    chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76117-001
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76117-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/31/2011
    Labeler - Okendpharma, Inc. (832814276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dextrum Laboratories Inc.007392322manufacture(76117-001)