Lortab Elixir (Hydrocodone Bitartrate / Acetaminophen) - Indications and Dosage

INDICATIONS AND USAGE

Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one tablespoonful every 4 to 6 hours as needed for pain. The total daily dosage for adults should not exceed 6 tablespoonfuls. The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.27 mL/kg of Lortab Elixir (providing 0.135 mg/kg of hydrocodone bitartrate and 9 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.

The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of Lortab Elixir be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that care givers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct care givers to use extreme caution in measuring the dosage.

HOW SUPPLIED

Lortab ® Elixir (hydrocodone bitartrate and acetaminophen oral solution) is a yellow-colored tropical fruit punch flavored liquid containing hydrocodone bitartrate 7.5 mg and acetaminophen 500 mg per 15 mL, with 7% alcohol. It is supplied in containers of 1 pint (473 mL) NDC 50474-909-16

STORAGE

Store at 20 to 25° C (68 to 77° F). [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container with a child-resistant closure.

A schedule CIII Narcotic.

Manufactured for

UCB Pharma, Inc.

Smyrna, GA 30080

Manufactured by

Mikart Inc.

Atlanta, GA 30318

PATIENT INFORMATION LEAFLET

LORTAB® ELIXIR                                                                 CIII

(Hydrocodone Bitartrate and Acetaminophen Oral

Solution)

7.5 mg/500 mg per 15 mL

SUMMARY

Lortab (pronounced LOR-tab) is used to relieve moderate to moderately severe pain. You should not take Lortab Elixir if you are allergic to hydrocodone or acetaminophen. The most common side effects of Lortab Elixir are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Take this medicine as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

USES

Lortab Elixir is an analgesic used to relieve moderate to moderately severe pain. Lortab Elixir is a combination product containing hydrocodone (hye-droe-KO-done) bitartrate and acetaminophen (a-seat-a-MIN-oh-fen). Hydrocodone is a narcotic pain reliever and a cough suppressant. Acetaminophen is a non-narcotic pain reliever and fever reducer. A narcotic analgesic and acetaminophen used together may provide better pain relief than either product used alone. If you have any questions, please call your doctor or pharmacist.