Zegesic (Acetaminophen / Phenyltoloxamine Citrate) - Indications and Dosage

INDICATIONS AND USAGE

For the temporary relief of mild to moderate pain associated with tension headaches, musculoskeletal injury, dysmenorrhea, colds and flu, sinus pain, toothaches, as well as for minor pain from arthritis, and to help reduce fever.

DOSAGE AND ADMINISTRATION

Adults and children over 12 years of age: 1 to 2 tablets every 8 to 12 hours, not to exceed 6 tablets in 24 hours.

Children 6 to 12 years: As prescribed by physician.

Not recommended for children under 6 years of age.

Tablets should not be chewed or crushed prior to swallowing. Do not exceed recommended dosage.

HOW SUPPLIED

Zgesic Tablets are supplied as white, capsule-shaped tablets debossed "ZGESIC" on one side, the opposite side is plain. Available in bottles of 90 tablets, NDC 64543- 400-90.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Dispense in tight, light-resistant containers as defined in the USP/NF, with child resistant closures.

Store at controlled room temperature between 20°- 25°C (68°- 77°F); see USP Controlled Room Temperature. Avoid exposure to heat.

Manufactured for:

Capellon Pharmaceuticals, LLC
Fort Worth, TX  76118

Rev. 06/2010   500367