GUAIFENESIN AND CODEINE PHOSPHATE  - guaifenesin and codeine phosphate solution 
Physicians Total Care, Inc.

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Guaifensin and Codeine Phosphate
Oral Solution USP
CV

ACTIVE INGREDIENTS

Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.

INACTIVE INGREDIENTS

Inactive Ingredients: Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol.

Sodium Content: 5 mg/5 mL

Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ

PURPOSE

This product combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough.

As a result, dry, unproductive coughs become more productive and less frequent.

INDICATIONS

Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients.

WARNINGS

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DRUG INTERACTION PRECAUTION

Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone. (See WARNINGS)

DOSAGE AND ADMINISTRATION

Take orally as stated below or use as directed by a physician. Adults and children 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; Children 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period; Children under 6 years: consult a physician. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a physician could result in serious side effects for a child. Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.

HOW SUPPLIED/STORAGE

Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms:

4 fl oz bottle (118 mL)
NDC 54868-0576-1
8 fl oz bottle (236 mL)
NDC 54868-0576-2


Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.



Pharmaceutical
Associates, Inc.

Greenville, SC 29605

R08/06


Relabeling of "Additional Barcode Label" by:


PRINCIPAL DISPLAY PANEL - 4 fl oz (118 mL) Bottle Label

Guaifenesin and Codeine
Phosphate Oral Solution USP
CV

4 fl oz (118 mL)

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant
container with a child-resistant closure.

DO NOT ACCEPT IF IMPRINTED SEAL
AROUND CAP IS BROKEN OR MISSING.

image of 4 fl oz package label


GUAIFENESIN AND CODEINE PHOSPHATE 
guaifenesin and codeine phosphate   solution
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54868-0576 (0121-0775)
Route of Administration ORAL DEA Schedule CV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
EDETATE DISODIUM  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GLYCERIN  
MENTHOL  
PROPYLENE GLYCOL  
WATER  
SODIUM BENZOATE  
SODIUM CITRATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color red Score     
Shape Size
Flavor CHERRY Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54868-0576-1 118 mL In 1 BOTTLE None
2 54868-0576-2 236 mL In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/05/2004 02/28/2011

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel
Revised: 12/2009 Physicians Total Care, Inc.