Label: CODAR GF- codeine phosphate, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2011

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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Codeine Phosphate* 8 mg
    *(Warning:  May be habit-forming)
    Guaifenesin 200 mg
  • Purpose

    Antitussive (Cough Suppressant)
    Expectorant
  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • Warnings

    Do not exceed recommended dosage.
  • Do not use this product

    • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  • Ask a doctor before use if you have

    • a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  These could be signs of a serious condition.
    • new symptoms occur
    • product may cause or aggravate constipation
  • If pregnant or breast-feeding,

    ask a health professional before use.
  • Keep out of the reach of children.

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

    Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.
    Adults and children
    12 years of age
    and over:

    		2 teaspoonfuls (10 mL)
    every 4 hours, not to
    exceed 12 teaspoonfuls
    in 24 hours
    Children 6 to under
    12 years of age:


    		1 teaspoonful (5 mL)
    every 4 hours, not to
    exceed 6 teaspoonfuls
    in 24 hours
    *Children under 6
    years of age
    		Consult a doctor
    *Giving a higher dose than recommended by a doctor could result in serious side effects for your child.
  • Other information

    Store at 15°- 30°C (59°- 86°F)
  • Inactive ingredients

    Bitter Mask, Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
  • Questions? Comments?

    Call (630) 543-3333

    Rx Only

    CV

    Manufactured for:
    RESPA
    PHARMACEUTICALS, INC.
    Addison, IL  60101
  • Product Packaging

    The packaging below represents the labeling currently used:

    Principal display panel and side panel for 473 mL label:

    NDC 60575-616-16
    ____________________________________

    Codar GF

    Expectorant / Cough Suppressant

    ____________________________________

    CV

    Each 5 mL (one teaspoonful) for oral
    administration contains:
    Codeine Phosphate*..............................8 mg
    *(Warning:  May be habit-forming)
    Guaifenesin.......................................200 mg

    Cotton Candy Flavor

    Rx Only

    RESPA
    PHARMACEUTICALS, INC.
    Addison, IL  60101

    16 fl oz. (473 mL)

    SEE ATTACHED PRODUCT INSERT FOR
    COMPLETE DOSING INFORMATION.

    Tamper evident by foil seal under cap.  Do not
    use if foil seal is broken or missing.

    Dispense in a tight, light-resistant container as
    defined in the USP/NF with a child-resistant
    closure.

    Store at controlled room temperature,
    15°-30°C (59°- 86°F).

    KEEP THIS AND ALL MEDICATIONS OUT
    OF THE REACH OF CHILDREN.

    Manufactured for:
    Respa Pharmaceuticals
    Addison, IL  60101

    Rx Only

    Rev. 05/11

    Codar GF Packaging


    Codar GF Packaging




  • INGREDIENTS AND APPEARANCE
    CODAR  GF
    codeine phosphate, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-616
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate8 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60575-616-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/21/2011
    Labeler - Respa Pharmaceuticals, Inc. (883901019)
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