Label: CODAR AR- chlorpheniramine maleate, codeine phosphate liquid

  • NDC Code(s): 60575-212-16
  • Packager: Respa Pharmaceuticals, Inc.
  • 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 June 20, 2011

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

  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)

    Chlorpheniramine Maleate 2 mg
    Codeine Phosphate * 8 mg
    *(Warning:  May be habit-forming)
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  • Purpose

    Antihistamine
    Antitussive (Cough Suppressant)
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  • Uses

    temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever or other upper respiratory allergies (allergic rhinitis).  Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants and helps you cough less.
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  • Warnings

    Do not exceed recommended dosage. Close
  • Do not take this product, unless directed by a doctor before use if you have

    • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • a chronic pulmonary disease, shortness of breath, or children who are taking other drugs
    • a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma
    • difficulty in urination due to enlargement of the prostate gland.
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  • Ask a doctor before use if you are

    taking sedatives or tranquilizers
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  • When using this product

    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
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  • Stop use and ask a doctor if

    • 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.
    • may cause or aggravate constipation.
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  • If pregnant or breast-feeding,

    ask a health professional before use.
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  • Keep this and other drugs out of the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.
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  • 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 12 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 6 teaspoonfuls
    in a 24 hour period.
    Children under 6
    years of age:
    Consult a doctor.

    A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.  Giving a higher dose than recommended by a doctor could result in serious effects for your child.
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  • Other information

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

    Apple 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.


    Addision, IL  60101
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  • Product Packaging

    The packaging below represents the labeling currently used:

    Principal display panel and side panel for 473 mL label:

    NDC 60575-212-16
    _____________________________________________

    Codar AR

    Antihistamine / Cough Suppressant
    _____________________________________________

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

    Chloropheniramine Maleate................................2 mg
    Codeine Phosphate*..........................................8 mg
    *(Warning:  May be habit-forming)

    CV

    Apple Flavor

    Rx Only

    RESPA
    PHARMACEUTICALS, INC.

    Addision, 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 AR Packaging


    Codar AR Packaging





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  • INGREDIENTS AND APPEARANCE
    CODAR  AR
    chlorpheniramine maleate, codeine phosphate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-212
    Route of Administration ORAL DEA Schedule CV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 2 mg  in 5 mL
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 8 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid (UNII: 2968PHW8QP)  
    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 APPLE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60575-212-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/20/2011
    Labeler - Respa Pharmaceuticals, Inc. (883901019)
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