TRICODE GF- codeine phosphate, guaifenesin, 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 GF

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

Codeine Phosphate* 8 mg
*(Warning:  May be habit-forming)
Guaifenesin 200 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Antitussive (Cough Suppressant)
Expectorant
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

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 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) 543-3333

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 60575-414-16
__________________________________________

Tricode® GF

Cough SuppressantŠ·Expectorant
Nasal Decongestant

__________________________________________

CV

Each 5 mL (one teaspoonful) for oral administration
contains:

Codeine Phosphate*.......................................8 mg
*(Warning:  May be habit-forming)
Guaifenesin................................................200 mg
Pseudoephedrine HCl....................................30 mg

Dye Free / Sugar Free
Alcohol Free / Gluten Free

Grape 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
Addison, IL  60101

Rx Only

Rev. 08/11
Tricode GF Packaging


Tricode GF Packaging


TRICODE  GF
codeine phosphate, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-414
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate8 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60575-414-16473 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: ba3af78f-2f38-48c7-94bf-36416da895a5
Set id: 2f65d1bb-a5cc-44a2-b7ea-bf7d3c92a870
Version: 2
Effective Time: 20110909
 
Respa Pharmaceuticals, Inc.