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  5. Label Information: Tricode GF

FDA Label for Tricode GF

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF THE REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS? COMMENTS?
    15. PRODUCT PACKAGING

Tricode GF Product Label

The following document was submitted to the FDA by the labeler of this product Respa Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredients(in each 5 mL teaspoonful)Codeine Phosphate* 8 mg*(Warning:  May be habit-forming)Guaifenesin 200 mgPseudoephedrine Hydrochloride 30 mg

Purpose



Antitussive (Cough Suppressant)ExpectorantNasal Decongestant

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

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, 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

When Using This Product



  • May cause or aggravate constipation

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

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



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



Bitter Mask, Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?



Call (630) 543-3333Rx OnlyCVManufactured 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 60575-414-16__________________________________________Tricode® GFCough SuppressantŠ·ExpectorantNasal Decongestant__________________________________________CVEach 5 mL (one teaspoonful) for oral administrationcontains:Codeine Phosphate*.......................................8 mg*(Warning:  May be habit-forming)Guaifenesin................................................200 mgPseudoephedrine HCl....................................30 mgDye Free / Sugar FreeAlcohol Free / Gluten FreeGrape Flavor Rx OnlyRESPA®PHARMACEUTICALS, INC.Addison, IL  6010116 fl oz. (473 mL)SEE ATTACHED PRODUCT INSERT FOR COMPLETEDOSING INFORMATION.Tamper evident by foil seal under cap.  Do not use iffoil seal is broken or missing.THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.Dispense in a tight, light-resistant container as definedin 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 PharmaceuticalsAddison, IL  60101Rx OnlyRev. 08/11

* Please review the disclaimer below.