BIO-B KIDS (DEXTROMETHORPHAN,CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]

BIO-B KIDS (DEXTROMETHORPHAN,CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-218-16
Set ID 0f33f96c-0817-47e7-95a8-456d34a98559
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 4 mg................................Antihistamine

    Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

    Phenylephrine HCl 10 mg.................................. Decongestant

  • PURPOSE


    Uses

    • temporarily relieves these symptoms due to cold, hay fever or other upper respiratory allergies
    • runny nose, sneezing, itching of the nose or throat, and itchy watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • WARNINGS

    Warnings

    • ask your doctor before use if you have
    • heart disease
    • diabetes
    • high blood pressure
    • thyroid disease
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

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

    Warning 

    Do not use 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 drug that contains an MAOI; ask your doctor or pharmacist before taking this product.

  • DO NOT USE


    Stop Use and ask a doctor if
    • You get nervous, dizzy or sleepless
    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
    When using this product
    • do not exceed recommended dosage
    • may cause excitability especially in children
    • may cause drowsiness, alcohol, sedatives, tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverage while taking this product
    • use caution when driving a motor vehicle or operating machinery
  • 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 right away.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed 6 doses in 24 hours.

    adults and children 12 years of age and over take 1 teaspoonful (5 mL) every 4 to 6 hours

    children 6 to under 12 years of age take 1/2 teaspoonful (2.5 mL) every 4 to 6 hours

    children under 6 years of age  consult a doctor

  • INDICATIONS & USAGE

    Other information  store at room temperature 15°- 30°C (59° - 86°F). Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering

    Tamper Evident Feature:
    Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

  • QUESTIONS

    Questions or comments? 1-305-403-3788
    Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
    www.advancedgeneric.com

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, propylene glycol, methylparaben, propylparaben, saccharin sodium, citric acid, sodium citrate, FD and C Red No. 40, strawberry flavor and purified water

  • PRINCIPAL DISPLAY PANEL

    BioBKidsLabel

  • INGREDIENTS AND APPEARANCE
    BIO-B KIDS 
    dextromethorphan,chlorpheniramine maleate, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-218
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide15 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE 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)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (Strawberry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-218-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2009
    Labeler - Advanced Generic Corporation (831762971)