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Carbaphen CH (Gil Pharmaceutical Corp)

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SUSPENSION 473 mL in 1 BOTTLE (58552-127-16) Label Information

Complete Carbaphen CH Information

  • Active ingredient

    Chlophedianol HCl 24 mg

    Chlorpheniramine maleate 4 mg

    Phenylephrine HCl 10 mg


  • Purpose

    Antitussive

    Antihistamine

    Nasal Decongestant


  • Uses

    Temporarily relieves:

    • cough due to the common cold.
    • runny nose and sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
    • nasal congestion due to the common cold.

  • Warnings

    Do not use
    • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if you have
    • asthma
    • emphysema
    • glaucoma
    • diabetes
    • excessive phlegm (mucus)
    • breathing problems
    • chronic bronchitis
    • persistent or chronic cough
    • cough associated with smoking
    • trouble urinating due to enlarged prostate gland
    • a sodium-restricted diet
    • thyroid disorders
    • heart disease
    • high blood pressure

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

    When using this product
    • do not use more than directed
    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if
    • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts, or sleeplessness. 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.

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • use 5 mL dose cup or teaspoon
    • do not exceed 4 doses in 24 hours
    Adults and children 12 years of age and older: 5 mL [1 teaspoon] every 6 to 8 hours.
    Children 6 to 12 years of age: 2.5 mL [1/2 teaspoon] every 6 to 8 hours.
    Children under 6 years of age: Consult a doctor.

  • Other information

    • store at room temperature

  • Inactive ingredients

    banana flavor, benzoic acid, blueberry flavor, citric acid, ethyl alcohol, glycerin, methylparaben, natural masking agent, propylene glycol, propylparaben, sodium citrate, sorbital, sucralose, water, and xanthan gum.


  • Questions

    Call Gil Pharmaceuticals Corp. at 787-848-9114, Mon.-Fri. 8:00 am to 5:00 pm, EST.


    Manufactured for:

    GIL Pharmaceuticals Corp.

    Ponce, Puerto Rico 00716


    PI383

    Rev. 12/11

    7185


  • Package/Label Principal Display Panel

    Image of Container Label - 473 mL

    NDC 58552-127-16

    CARBAPHEN CH®

    Great Blueberry Banana Flavor Suspension

    ANTITUSSIVE, ANTIHISTAMINE, AND NASAL DECONGESTANT

    New Improved FORMULA!

    SUGAR FREE

    Each 5 mL contains:

    Chlophedianol HCI........................24 mg

    Chlorpheniramine Maleate..............4 mg

    Phenylephrine HCI.........................10 mg

    1 Pint (473 mL)

     

    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00716


  • INGREDIENTS AND APPEARANCE
    CARBAPHEN CH 
    chlophedianol hcl, chlorpheniramine maleate, and phenylephrine suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-127
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE 24 mg  in 5 mL
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BLUEBERRY, BANANA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-127-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/29/2011
    Labeler - Gil Pharmaceutical Corp (176826592)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 833205789 MANUFACTURE(58552-127)