Guaifenesin

Pack Pharmaceuticals LLC

Guaifenesin AC CV Cough Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*

• INACTIVE INGREDIENTS
• INDICATIONS
• DIRECTIONS
• WARNINGS
• DRUG INTERACTION PRECAUTION
• OTHER INFORMATION
• PRINCIPAL DISPLAY PANEL - 473 mL Bottle

FULL PRESCRIBING INFORMATION

INACTIVE INGREDIENTS

Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

INDICATIONS

Temporarily relieves 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.

DIRECTIONS

Take every 4 hours or as directed by a doctor . Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: Do not use. Giving a higher dose than recommended by a doctor could result in serious side effects for your child. Do not exceed recommended dosage.

WARNINGS

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 doctor . 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 doctor. 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 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.

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 product used alone.

Dispense in a tight, light-resistant container as defined in the USP.

Store at controlled room temperature 20°-25° C (68 °-77°F). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

OTHER INFORMATION

Each 5 mL contains: sodium 4 mg

TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.

TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

NDC 16571-302-16
TAMPER-EVIDENT
DO NOT REFRIGERATE

Guaifenesin AC CV
Cough Syrup

(GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP)

COUGH SUPPRESSANT • EXPECTORANT

Each teaspoon (5mL) contains:
Guaifenesin USP                  100 mg
Codeine Phosphate USP      10 mg
contains 3.5% alcohol v/v

*Under Federal law Guaifenesin AC
is available without a prescription.
Certain State laws may differ.

Manufactured by:
Bio-Pharm, Incorporated Levittown, PA 19057
Distributed by: PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089     REV 08/09

TO REPORT ADVERSE DRUG EVENTS CALL:
(866) 562-4597

ONE PINT (473 mL)

PACK
PHARMACEUTICALS, LLC