TRICODE AR- chlorpheniramine maleate, codeine phosphate, pseudoephedrine hydrochloride liquid 
Respa Pharmaceuticals, Inc.

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.

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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

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:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

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




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)

Revised: 9/2011
Document Id: cfbbbfc0-ceb1-42b7-927b-6dcc58e30f1f
Set id: 2548c67a-dfff-4cfb-8f51-a1006cf54a2f
Version: 2
Effective Time: 20110909
 
Respa Pharmaceuticals, Inc.