Label: TRICODE GF- codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid

  • NDC Code(s): 60575-414-16
  • 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 September 9, 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)
    Guaifenesin 200 mg
    Pseudoephedrine Hydrochloride 30 mg
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  • Purpose

    Antitussive (Cough Suppressant)
    Expectorant
    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
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
    • 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, chronic bronchitis 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
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  • When using this product

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

    • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
    • nervousness, dizziness, or sleeplessness occur
    • new symptoms occur
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  • If pregnant or breast-feeding,

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

    In case of accidental 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 to 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 to 6 hours, not to
    exceed 4 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 side effects for your child.
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  • Other information

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

    Bitter Mask, Citric Acid, Glycerin, Grape Flavor, 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 panel for 473 mL label:

    NDC 60575-414-16
    __________________________________________

    Tricode® GF

    Cough SuppressantĀŠ·Expectorant
    Nasal Decongestant

    __________________________________________

    CV

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

    Codeine Phosphate*.......................................8 mg
    *(Warning:  May be habit-forming)
    Guaifenesin................................................200 mg
    Pseudoephedrine HCl....................................30 mg

    Dye Free / Sugar Free
    Alcohol Free / Gluten Free

    Grape 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.

    THIS BOTTLE IS NOT TO BE DISPENSED TO
    THE CONSUMER.


    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. 08/11
    Tricode GF Packaging


    Tricode GF Packaging


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  • INGREDIENTS AND APPEARANCE
    TRICODE  GF
    codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60575-414
    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
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 200 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 GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60575-414-16 473 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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