Codeine Phosphate and Guaifenesin

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

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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 49769-323-16 473 mL In 1 BOTTLE None

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: 03/2011Kylemore Pharmaceuticals, LLC

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