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Lortab: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule II Boxed warning
Strength:
10 mg/15 mL, 300 mg/15 mL
Other brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Lortab

Possible Side Effects

Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.

Call your doctor if these effects continue or are bothersome.

Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor.

Storage

  • Keep out of reach of children.
  • Store at room temperature (protect from heat, do not refrigerate).
  • Keep in original labeled bottle.
  • Discard medicines that are old or no longer needed.
  • Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.
  • This leaflet provides a summary of information about LORTAB ELIXIR. If you have any question or concerns, or want more information about LORTAB ELIXIR, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about LORTAB ELIXIR that is written for health professionals that you can ask to read.

Prepared by: LO00N Code 1059D00 Rev. 01/15 Akorn, Inc.

Patient Information Leaflet LORTAB

® ELIXIR CII (hydrocodone bitartrate and acetaminophen oral solution) 10 mg/300 mg per 15 mL Rx only

LORTAB (pronounced LOR-tab) ELIXIR 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. Summary

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.

General Cautions

  • Do not take this drug if you have allergies or unusual reactions to narcotic pain relievers or acetaminophen because it is likely that you may also be allergic to LORTAB ELIXIR.

  • This product may inhibit your mental and physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while you are taking this product.

  • This medicine may not be right for you. Check with your doctor or pharmacist, if you:

    • are pregnant.
    • are nursing.
    • are taking other medications: narcotic pain relievers; allergy medicines; antidepressant medicines; acetaminophen-containing medicines or other medicines that cause central nervous system depression, including alcohol.
    • have other medical problems: a history of drug or alcohol abuse; recent head injury; emphysema, asthma, or other chronic lung disease; liver disease, kidney disease; underactive thyroid, Addison's disease, enlarged prostate or difficulty urinating.

Proper Use

Take this medicine as directed by your doctor. Do not share it with anyone else. This medicine can cause drug dependence and has the potential for abuse. 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. If you think that this medicine is not working properly after taking it for some time, do not increase the dose. Check with your doctor or pharmacist.

Dosing

The dose of this medication will be different for different patients. Follow the directions provided by your doctor. The following information includes only the average doses of this medication. . If your dose is different, do not change doses unless your doctor tells you to do so

BODY WEIGHTAPPROXIMATE AGEDOSE every 4 to 6 hoursMAXIMUM TOTAL DAILY DOSE (6 doses per day)
12 to 15 kg (27 to 34 lbs.)2 to 3 years2.8 mL16.8 mL
16 to 22 kg (35 to 50 lbs.)4 to 6 years3.75 mL22.5 mL
23 to 31 kg (51 to 69 lbs.)7 to 9 years5.6 mL33.6 mL
32 to 45 kg (70 to 100 lbs.)10 to 13 years7.5 mL45 mL
46 kg and up (101 lbs. and up)14 years to adult11.25 mL67.5 mL

It is very important that LORTAB ELIXIR be dosed accurately. It is strongly recommended that you obtain and use a proper measuring device. Ask your doctor or pharmacist for help to find a dropper that can measure the needed dose properly and ask for help if you do not understand how to use the dropper.

Missed Dose

  • To avoid a possible overdose, it is important that you do not take more than a single dosage at one time, or that you don't take doses at intervals less than 4 hours apart.
  • If you miss taking a dose of LORTAB ELIXIR, take it as soon as you remember. However, make sure to wait at least 4 hours before taking your next dose.
  • If you missed taking a dose, and it is almost time for your next dose, skip the missed dose and take your medicine as scheduled.
  • Do not double the prescribed dose.

Possible Side Effects

Side effects you may experience include abdominal pain, constipation, difficulty urinating, dizziness, drowsiness, fear, fuzzy thinking, general feeling of discomfort or illness, light-headedness, mood changes, nausea, nervousness, rash, shortness of breath, slower reactions, unusual tiredness, and vomiting.

Call your doctor if these effects continue or are bothersome.

Side effects not listed above may sometimes occur. If you notice any other effects, check with your doctor.

Storage

  • Keep out of reach of children.
  • Store at room temperature (protect from heat, do not refrigerate).
  • Keep in original labeled bottle.
  • Discard medicines that are old or no longer needed.
  • Even a single overdose of this medicine may be a life-threatening situation. If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. This medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.
  • This leaflet provides a summary of information about LORTAB ELIXIR. If you have any question or concerns, or want more information about LORTAB ELIXIR, contact your doctor or pharmacist. Your pharmacist also has a longer leaflet about LORTAB ELIXIR that is written for health professionals that you can ask to read.

Prepared by: Code 1059D00-P Rev. 01/15 Akorn, Inc.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 040881 · View the label on DailyMed

Revision date stated in the text: January 2015

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Lortab

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IISchedule II: high potential for abuse; abuse may lead to severe psychological or physical dependence.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Opioid Agonist
Active ingredients Hydrocodone bitartrate 10 mg/15 mL, Acetaminophen 300 mg/15 mL
Dosage form Syrup
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) PHARMOBEDIENT
FDA approval ANDA 040881Abbreviated New Drug Application (ANDA) – generic drug Approved February 25, 2010
Packages (NDC)
Package
10 mg/15 mL, 300 mg/15 mL – 15 ml in 1 cup, unit-dose NDC 17856-0450-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.