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  5. Label Information: Tricode AR

FDA Label for Tricode AR

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. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF THE REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRODUCT PACKAGING

Tricode AR 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)Chlorpheniramine Maleate 2 mgCodeine Phosphate* 8 mg*WARNING:  May be habit formingPseudoephedrine Hydrochloride 30 mg

Purpose



AntihistamineAntitussive (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) 543-3333Rx 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 60575-313-16____________________________________________Tricode AR®Antihistamine·Cough Suppressant Nasal Decongestant____________________________________________Each 5 mL (one teaspoonful) for oral administrationcontains:Chlorpheniramine Maleate.................................2 mgCodeine Phosphate*.........................................8 mg*(Warning:  May be habit-forming)Pseudoephedrine HCl......................................30 mgDye Free / Sugar FreeAlcohol Free / Gluten FreeBerry Vanilla FlavorRx 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 if foilseal 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 REACHOF CHILDREN.Manufactured for:Respa PharmaceuticalsAddision, IL  60101Rx OnlyRev. 08/11

* Please review the disclaimer below.