Tricode AR

Dosage form: liquid
Ingredients: Chlorpheniramine Maleate 2mg in 5mL, Codeine Phosphate 8mg in 5mL, Pseudoephedrine Hydrochloride 30mg in 5mL
Labeler: Respa Pharmaceuticals, Inc.
NDC Code: 60575-313

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.

Tricode AR

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

PurposeAntihistamine
Antitussive (Cough Suppressant)
Nasal Decongestant

Usestemporarily 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 aretaking 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 informationStore at 15°- 30°C (59°- 86°F)

Inactive ingredientsBerry 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 PackagingThe 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
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 (Chlorpheniramine) Chlorpheniramine Maleate2 mg  in 5 mL
Codeine Phosphate (Codeine) Codeine Phosphate8 mg  in 5 mL
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY, VANILLAImprint Code
Contains    
Packaging
#Item CodePackage Description
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)

Revised: 09/2011
 
Respa Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)