POLY-TUSSIN

Poly Pharmaceuticals, Inc.
Great Southern Laboratories

POLY-TUSSIN EX

FULL PRESCRIBING INFORMATION: CONTENTS*

• Poly-Tussin EX Syrup
• CLINICAL PHARMACOLOGY
• POLY-TUSSIN INDICATIONS AND USAGE
• POLY-TUSSIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• Drug Interactions:
• Information for Patients:
• Pregnancy:
• Labor and Delivery:
• Nursing Mothers:
• Pediatric Use:
• Geriatric Use:
• POLY-TUSSIN ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• POLY-TUSSIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRODUCT PACKAGING:

FULL PRESCRIBING INFORMATION

Poly-Tussin EX Syrup

CLINICAL PHARMACOLOGY

POLY-TUSSIN INDICATIONS AND USAGE

POLY-TUSSIN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

Drug Interactions:

Information for Patients:

• This product may inhibit mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
• Report any adverse experiences occurring during therapy.
• Do not adjust the dose of this product without consulting the prescribing professional.
• Do not combine this product with alcohol or other central nervous system depressants.
• Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child.

Pregnancy:

Labor and Delivery:

Nursing Mothers:

Pediatric Use:

Geriatric Use:

POLY-TUSSIN ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

POLY-TUSSIN DOSAGE AND ADMINISTRATION

HOW SUPPLIED

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 50991-529-16

POLY-TUSSIN EX

Antitussive / Decongestant / Expectorant

Each 5 mL (1 teaspoonful) contains:
Dihydrocodeine Bitartrate*........ 7.5 mg
*(WARNING: May be habit forming)
Phenylephrine HCl.................... 5 mg
Guaifenesin............................ 50 mg

Grape Flavor
Alcohol Free / Gluten Free
Sugar Free / Dye Free

CIII

Rx Only

Distributed by:
Poly Pharmaceuticals
Mobile, AL 36619

16 fl oz. (473 mL)

Side Panel:

Adults and children over 12 years: 1 to 2 teaspoonfuls (5 mL to 10 mL) every 4 to 6 hours, as needed.

Children 6 to under 12 years of age: 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, as needed.

Not recommended for children under 6 years of age.

Refer to the attached package insert for full prescribing information.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE
OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT
A POISON CONTROL CENTER IMMEDIATELY.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Storage: Store at controlled room temperature, 15^o-30^oC (59^o-86^oF).

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

This bottle is not to be dispensed to consumer.

Rx Only

Manufactured by: Great Southern Laboratories, Houston, TX 77099

Distributed for: Poly Pharmaceuticals, Mobile, AL 36619

Iss. 09/09

Principal Display Panel and Side Panel for 15 mL Label: