LORTAB- hydrocodone bitartrate and acetaminophen syrup
Akorn, Inc.

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MEDICATION GUIDE

MEDICATION GUIDE
LORTAB (lor" tab) ELIXIR
(Hydrocodone Bitartrate and Acetaminophen Oral Solution), CII
LORTAB ELIXIR is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about LORTAB ELIXIR:
  • Get emergency help right away if you take too much LORTAB ELIXIR (overdose) . When you first start taking LORTAB ELIXIR, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking LORTAB ELIXIR with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your LORTAB ELIXIR. They could die from taking it. Store LORTAB ELIXIR away from children and in a safe place to prevent stealing or abuse. Selling or giving away LORTAB ELIXIR is against the law.
Do not take LORTAB ELIXIR if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in LORTAB ELIXIR.
Before taking LORTAB ELIXIR, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of LORTAB ELIXIR during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. LORTAB ELIXIR passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking LORTAB ELIXIR with certain other medicines can cause serious side effects that could lead to death.
When taking LORTAB ELIXIR:
  • Do not change your dose. Take LORTAB ELIXIR exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Always use a calibrated measuring device for LORTAB ELIXIR to correctly measure your dose. A household teaspoon or tablespoon is not an adequate measuring device. 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 caregivers obtain and use a calibrated measuring device.

BODY WEIGHT

APPROXIMATE AGE
DOSE
every 4 to 6 hours
MAXIMUM TOTAL DAILY DOSE
(6 doses per day)
12 to 15 kg
27 to 34 lbs.
2 to 3 years 2.8 mL 16.8 mL
16 to 22 kg
35 to 50 lbs.
4 to 6 years 3.75 mL 22.5 mL
23 to 31 kg
51 to 69 lbs.
7 to 9 years 5.6 mL 33.6 mL
32 to 45 kg
70 to 100 lbs.
10 to 13 years 7.5 mL 45 mL
46 kg and up
101 lbs. and up
14 years to adult 11.25 mL 67.5 mL
  • Take your prescribed dose. The usual adult dosage is 11.25 milliliters every four to six hours as needed for pain. The total daily dosage should not exceed 67.5 milliliters. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking LORTAB ELIXIR regularly, do not stop taking LORTAB ELIXIR without talking to your healthcare provider.
  • After you stop taking LORTAB ELIXIR, the unused solution should be disposed of by flushing down the toilet.
While taking LORTAB ELIXIR DO NOT:
  • Drive or operate heavy machinery, until you know how LORTAB ELIXIR affects you. LORTAB ELIXIR can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with LORTAB ELIXIR may cause you to overdose and die.
The possible side effects of LORTAB ELIXIR:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of LORTAB ELIXIR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured for: Akorn, Inc., Lake Forest, IL 60045

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 07/2018
Code 1059D00

Revised: 11/2018
Akorn, Inc.