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Codeine Phosphate and Guaifenesin

Dosage Form: oral liquid

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Codeine Phosphate 10 mg Guaifenesin 200 mg

Drug Facts

Active ingredients (in each 5 mL teaspoonful)
Codeine Phosphate* 10 mg ........ Antitussive
*WARNING: May be habit forming
Guaifenesin 200 mg ................. Expectorant

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Uses

·    temporarily relieves these symptoms due to the common cold:
·    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

·    do not take this product if you have chronic pulmonary disease, shortness of breath,or children who are taking other drugs, unless directed by a doctor.

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)

Stop use and ask a doctor if
·    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
·    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, seek professional assistance, or contact a Poison Control Center immediately.

Directions

Take this medication with a full glass of water after each dose to help loosen mucus in the lungs.


Inactive ingredients

Cherry Flavor, Citric Acid, Glycerin, Menthol
Crystals, Propylene Glycol, Purified Water,
Sodium Citrate, Sodium Saccharin, Sorbitol,
and Vanilla Flavor.

Other information
Store at 68° - 77° F (20° - 25° C)

Questions? Comments?

Call 1-866-934-6025
Manufactured for:
Kylemore Pharmaceuticals, LLC
Port St. Joe, FL 32456
323-10 Rev. 12/09

PACKAGING:

Codeine Phosphate 10 mg Guaifenesin 200 mg labeling:

CODEINE PHOSPHATE GUAIFENESIN 
codeine phosphate, guaifenesin liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-323
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
MENTHOL  
PROPYLENE GLYCOL  
WATER  
SODIUM CITRATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (cherry-vanilla) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:49769-323-16 473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2010 11/30/2012
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 03/2011
 
Kylemore Pharmaceuticals, LLC



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