Guaifenesin DAC

Pack Pharmaceuticals LLC

GUAIFENESIN DAC ORAL SOLUTION

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

INACTIVE INGREDIENTS

Alcohol 1.9%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

INDICATIONS

Temporarily relieves cough and nasal congestion as may occur with a cold. 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 4 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.

WARNINGS

Do not exceed recommended dosage.

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by 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. 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. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult 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

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 are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.

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.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle

NDC 16571-301-16
TAMPER-EVIDENT
DO NOT REFRIGERATE

GUAIFENESIN DAC
ORAL SOLUTION
CV

EXPECTORANT
NASAL DECONGESTANT
COUGH SUPPRESSANT

Each teaspoon (5 mL) Contains:
Guaifenesin USP                                100 mg
Pseudoephedrine Hydrochloride USP  30 mg
Codeine Phosphate USP                      10 mg
contains 1.9% alcohol v/v

*Under Federal law Guaifenesin DAC
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