Label: TRICODE AR- chlorpheniramine maleate, 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 September 9, 2011

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  • Drug Facts

    Active ingredients
    (in each 5 mL teaspoonful)
    Chlorpheniramine Maleate 2 mg
    Codeine Phosphate* 8 mg
    *WARNING:  May be habit forming
    Pseudoephedrine Hydrochloride 30 mg
  • Purpose

    Antihistamine
    Antitussive (Cough Suppressant)
    Nasal Decongestant
  • Uses

    temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • reduces swelling of nasal passages
  • 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 breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • 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
  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.
  • When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • 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.
    • may cause or aggravate constipation
    • nervousness, dizziness, or sleeplessness occur
    • new symptoms occur
  • If pregnant or breast-feeding,

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

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

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

    Berry Vanilla Flavor, Citric Acid, 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 60575-313-16
    ____________________________________________

    Tricode AR®

    Antihistamine·Cough Suppressant
    Nasal Decongestant
    ____________________________________________



    Each 5 mL (one teaspoonful) for oral administration
    contains:
    Chlorpheniramine Maleate.................................2 mg
    Codeine Phosphate*.........................................8 mg
    *(Warning:  May be habit-forming)
    Pseudoephedrine HCl......................................30 mg

    Dye Free / Sugar Free
    Alcohol Free / Gluten Free

    Berry Vanilla 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
    Addision, IL  60101

    Rx Only

    Rev. 08/11

    Tricode AR Packaging


    Tricode AR Packaging
  • INGREDIENTS AND APPEARANCE
    TRICODE  AR
    chlorpheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-313
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate2 mg  in 5 mL
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate8 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 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
    FlavorBERRY, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60575-313-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/20/2011
    Labeler - Respa Pharmaceuticals, Inc. (883901019)
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