Codar GF

Dosage form: liquid
Ingredients: Codeine Phosphate 8mg in 5mL, Guaifenesin 200mg in 5mL
Labeler: Respa Pharmaceuticals, Inc.
NDC Code: 60575-616

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.

Codar GF

Drug Facts Active ingredients
(in each 5 mL teaspoonful)

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

PurposeAntitussive (Cough Suppressant)
Expectorant

Usestemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

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 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
  • trouble urinating due to an enlarged prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.  These could be signs of a serious condition.
  • new symptoms occur
  • product may cause or aggravate constipation

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.

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

Inactive ingredientsBitter 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 PackagingThe 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
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 (Codeine) Codeine Phosphate8 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Citric Acid 
Glycerin 
Propylene Glycol 
Water 
Sodium Citrate 
Saccharin Sodium 
Sorbitol 
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage Description
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: 06/2011
 
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.

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