HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Main information

  • Trade name:
  • HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate and acetaminophen tablet
  • Composition:
  • HYDROCODONE BITARTRATE 5 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate and acetaminophen tablet
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS ), reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - have not been tolerated, or are not expected to be tolerated, have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: - Significant respiratory depression (see WARNINGS ) Significant respiratory depression (see WARNINGS ) - Acute or severe bronchial asthma in an unmonitor
  • Product summary:
  • Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows: Strength How Supplied Each tablet contains: Description of tablet Hydrocodone Bitartrate Acetaminophen 5 mg/ 325 mg Bottles of 20 …………..… NDC 0406-0123-20 Bottles of 30 …………..… NDC 0406-0123-30 Bottles of 60 …………..… NDC 0406-0123-60 Bottles of 90 …………..… NDC 0406-0123-90 Bottles of 100 …………… NDC 0406-0123-01 Bottles of 120 ..………..… NDC 0406-0123-12 Bottles of 500 …………… NDC 0406-0123-05 Bottles of 1000 ………..… NDC 0406-0123-10 Unit Dose (10 x 10) …….. NDC 0406-0123-62 5 mg 325 mg It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. 7.5 mg/ 325 mg Bottles of 20 …………..… NDC 0406-0124-20 Bottles of 30 …………..… NDC 0406-0124-30 Bottles of 60 …………..… NDC 0406-0124-60 Bottles of 90 …………..… NDC 0406-0124-90 Bottles of 100 …………… NDC 0406-0124-01 Bottles of 120 ..………..… NDC 0406-0124-12 Bottles of 500 …………… NDC 0406-0124-05 Bottles of 1000 ………..… NDC 0406-0124-10 Unit Dose (10 x 10) …….. NDC 0406-0124-62 7.5 mg 325 mg It is available as an unscored oval-shaped white tablet debossed with M366 on one side. 10 mg/ 325 mg Bottles of 20 …………..… NDC 0406-0125-20 Bottles of 30 …………..… NDC 0406-0125-30 Bottles of 60 …………..… NDC 0406-0125-60 Bottles of 90 …………..… NDC 0406-0125-90 Bottles of 100 …………… NDC 0406-0125-01 Bottles of 120 ..………..… NDC 0406-0125-12 Bottles of 500 …………… NDC 0406-0125-05 Bottles of 1000 ………..… NDC 0406-0125-10 Unit Dose (10 x 10) …….. NDC 0406-0125-62 10 mg 325 mg It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2018 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 07/ 2018 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/ Medguide/ MG20H32.pdf or by calling 1-800-778-7898 for alternate delivery options.

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0406-0123-01, 0406-0123-05, 0406-0123-10, 0406-0123-12, 0406-0123-20, 0406-0123-23, 0406-0123-30, 0406-0123-60, 0406-0123-62, 0406-0123-90, 0406-0124-01, 0406-0124-05, 0406-0124-10, 0406-0124-12, 0406-0124-20, 0406-0124-23, 0406-0124-30, 0406-0124-60, 0406-0124-62, 0406-0124-90, 0406-0125-01, 0406-0125-05, 0406-0125-10, 0406-0125-12, 0406-0125-20, 0406-0125-23, 0406-0125-30, 0406-0125-60, 0406-0125-62, 0406-0125-90
  • Last update:
  • 16-06-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

acetaminophen tablet

SpecGx LLC

----------

Medication Guide

Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen)

Tablets CII

Hydrocodone bitartrate and acetaminophen tablets are:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain

severe enough to require an opioid pain medicine, 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 hydrocodone bitartrate and acetaminophen tablets:

Get emergency help right away if you take too many hydrocodone bitartrate and acetaminophen

tablets (overdose). When you first start taking hydrocodone bitartrate and acetaminophen tablets,

when your dose is changed, or if you take too many (overdose), serious or life-threatening

breathing problems that can lead to death may occur.

Taking hydrocodone bitartrate and acetaminophen tablets 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 hydrocodone bitartrate and acetaminophen tablets. They could die

from taking it. Store hydrocodone bitartrate and acetaminophen tablets away from children and in

a safe place to prevent stealing or abuse. Selling or giving away hydrocodone bitartrate and

acetaminophen tablets is against the law.

Do not take hydrocodone bitartrate and acetaminophen tablets 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 hydrocodone and

acetaminophen tablets.

Before taking hydrocodone bitartrate and acetaminophen tablets, 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 hydrocodone bitartrate and

acetaminophen tablets during pregnancy can cause withdrawal symptoms in your newborn baby

that could be life-threatening if not recognized and treated.

breastfeeding. Hydrocodone bitartrate and acetaminophen passes into breast milk and may harm

your baby.

taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking

hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious

side effects that could lead to death.

When taking hydrocodone bitartrate and acetaminophen tablets:

Do not change your dose. Take hydrocodone bitartrate and acetaminophen tablets exactly as

prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

Take your prescribed dose every four to six hours as needed for pain.

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 hydrocodone bitartrate and acetaminophen tablets regularly, do not stop

taking hydrocodone bitartrate and acetaminophen tablets without talking to your healthcare

provider.

After you stop taking hydrocodone bitartrate and acetaminophen tablets, the unused tablets should

be disposed of by flushing down the toilet.

While taking hydrocodone bitartrate and acetaminophen tablets DO NOT:

Drive or operate heavy machinery, until you know how hydrocodone bitartrate and

acetaminophen tablets affect you. Hydrocodone bitartrate and acetaminophen tablets 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 hydrocodone bitartrate and acetaminophen

tablets may

cause you to overdose and die.

The possible side effects of hydrocodone bitartrate and acetaminophen tablets:

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 hydrocodone bitartrate and acetaminophen tablets. 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 by: SpecGx LLC, Webster Groves, MO 63119 USA, www.Mallinckrodt.com or call 1-

800-778-7898

Mallinckrodt™

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

Issued: 06/2017

MG20H32

Revised: 10/2018

Document Id: bf622ac9-0f34-4947-b97a-a2641c0b7289

34391-3

Set id: 73c1059b-0c7d-42ef-9827-f018858fc447

Version: 45

Effective Time: 20181004

SpecGx LLC