CODAR GF- codeine phosphate, guaifenesin 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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Codar GF

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)

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

Purpose

Antitussive (Cough Suppressant)
Expectorant

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

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

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.
Adults and children
12 years of age
and over:

2 teaspoonfuls (10 mL)
every 4 hours, not to
exceed 12 teaspoonfuls
in 24 hours
Children 6 to under
12 years of age:


1 teaspoonful (5 mL)
every 4 hours, not to
exceed 6 teaspoonfuls
in 24 hours
*Children under 6
years of age
Consult a doctor

*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, Cotton Candy Flavor, 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 60575-616-16
____________________________________

Codar GF

Expectorant / Cough Suppressant

____________________________________

CV

Each 5 mL (one teaspoonful) for oral
administration contains:
Codeine Phosphate*..............................8 mg
*(Warning:  May be habit-forming)
Guaifenesin.......................................200 mg

Cotton Candy 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.

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. 05/11

Codar GF Packaging


Codar GF Packaging




CODAR  GF
codeine phosphate, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60575-616
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
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
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60575-616-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2011
Labeler - Respa Pharmaceuticals, Inc. (883901019)

Revised: 6/2011
Document Id: 1e3023d2-63bb-4367-9152-84ed9adcd90f
Set id: 6eda2c06-fb11-4a58-98fb-4eafe1d1df5f
Version: 1
Effective Time: 20110623
 
Respa Pharmaceuticals, Inc.