Label: CODAR D- codeine phosphate, pseudoephedrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • 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 July 26, 2011

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Codeine Phosphate* 8 mg
    *(Warning:  May be habit-forming)
    Pseudoephedrine Hydrochloride 30 mg
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  • Purpose

    Cough Suppressant
    Nasal Decongestant
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  • 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
    • nasal congestion
    • reduces swelling of nasal passages
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  • Warnings

    Do not exceed recommended dosage. Close
  • 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.
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  • 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 mellitus
    • difficulty in urination due to an enlarged prostate gland
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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.
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  • When using this product

    • may cause or aggravate constipation
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  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough or nasal congestion 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
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  • If pregnant or breast-feeding,

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

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

    Do not exceed recommended dosage.
    Adults and Children
    12 years of age and
    over:
    2 teaspoonfuls (10 mL)
    every 4-6 hours, not to
    exceed 8 teaspoonfuls
    in a 24 hour period.
    Children 6 to under
    12 years of age:
    1 teaspoonful (5 mL)
    every 4-6 hours, not to
    exceed 4 teaspoonfuls
    in a 24 hour period.
    Children under 6
    years of age:
    Not recommended
    for use.

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  • Other information

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

    Berry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol
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  • Questions? Comments?

    Call (630) 543-3333

    Rx Only

    CV

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

    The packaging below represents the labeling currently used:

    Principal display panel and side pane for 473 mL label:

    NDC 60575-515-16
    _____________________________________
    Codar® D

    Cough Suppressant / Nasal Decongestant
    _____________________________________


    CV

    Each 5 mL (one teaspoonful) for oral
    administration contains:

    Codeine Phosphate*..............................8 mg
    Pseudoephedrine HCl...........................30 mg

    Berry 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. 06/11

    Codar D Packaging


    Codar D Packaging

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  • INGREDIENTS AND APPEARANCE
    CODAR   D
    codeine phosphate, pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-515
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 8 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride 30 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60575-515-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/13/2011
    Labeler - Respa Pharmaceuticals (883901019)
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