FDA Label for Codar GF
View Indications, Usage & Precautions
Codar GF Product Label
The following document was submitted to the FDA by the labeler of this product Respa Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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:
- 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.
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 |
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) 543-3333Rx OnlyCVManufactured for:RESPAPHARMACEUTICALS, 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 GFExpectorant / Cough Suppressant____________________________________CVEach 5 mL (one teaspoonful) for oraladministration contains:Codeine Phosphate*..............................8 mg*(Warning: May be habit-forming)Guaifenesin.......................................200 mgCotton Candy FlavorRx OnlyRESPAPHARMACEUTICALS, INC.Addison, IL 6010116 fl oz. (473 mL)SEE ATTACHED PRODUCT INSERT FOR COMPLETE DOSING INFORMATION.Tamper evident by foil seal under cap. Do notuse if foil seal is broken or missing.Dispense in a tight, light-resistant container asdefined in the USP/NF with a child-resistantclosure.Store at controlled room temperature,15°-30°C (59°- 86°F).KEEP THIS AND ALL MEDICATIONS OUTOF THE REACH OF CHILDREN.Manufactured for:Respa PharmaceuticalsAddison, IL 60101Rx OnlyRev. 05/11
* Please review the disclaimer below.