Label: CONZIP- tramadol hcl 200mg tablet, film coated, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 23, 2020

If you are a consumer or patient please visit this version.

  • Medication Guide Section

    MEDICATION GUIDE

    Tramadol Hydrochloride (tram a dol hye droe klor ide) Extended-Release Tablets, USP CIV

    Tramadol Hydrochloride Extended-Release Tablets are:

    A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

    A long-acting (extended-release) 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.

    Not for use to treat pain that is not around-the-clock.

    Important information about Tramadol Hydrochloride Extended-Release Tablets:

    Get emergency help right away if you take too much Tramadol Hydrochloride Extended-Release Tablets (overdose). When you first start taking Tramadol Hydrochloride Extended-Release Tablets, 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 Tramadol Hydrochloride Extended-Release 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 Tramadol Hydrochloride Extended-Release Tablets. They could die from taking it. Selling or giving away Tramadol Hydrochloride Extended-Release Tablets is against the law.

    Store Tramadol Hydrochloride Extended-Release Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

    Important Information Guiding Use in Pediatric Patients:

    Do not give Tramadol Hydrochloride Extended-Release Tablets to a child younger than 12 years of age.
    Do not give Tramadol Hydrochloride Extended-Release Tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
    Avoid giving Tramadol Hydrochloride Extended-Release Tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

    Do not take Tramadol Hydrochloride Extended-Release Tablets if you have:

    severe asthma, trouble breathing, or other lung problems.

    a bowel blockage or have narrowing of the stomach or intestines.

    Before taking Tramadol Hydrochloride Extended-Release 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 Tramadol Hydrochloride Extended-Release Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life- threatening if not recognized and treated.

    breastfeeding. Not recommended. It may harm your baby.

    taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Tramadol Hydrochloride Extended-Release Tablets with certain other medicines can cause serious side effects that could lead to death.

    When taking Tramadol Hydrochloride Extended-Release Tablets:

    Do not change your dose. Take Tramadol Hydrochloride Extended-Release Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

    Take your prescribed dose once a day at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

    Swallow Tramadol Hydrochloride Extended-Release Tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject Tramadol Hydrochloride Extended-Release Tablets because this may cause you to overdose and die.

    Call your healthcare provider if the dose you are taking does not control your pain.

    Do not stop taking Tramadol Hydrochloride Extended-Release Tablets without talking to your healthcare provider.

    Dispose of expired, unwanted, or unused Tramadol Hydrochloride Extended-Release Tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of Tramadol Hydrochloride Extended-Release Tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.

    While taking Tramadol Hydrochloride Extended-Release Tablets DO NOT:

    Drive or operate heavy machinery, until you know how Tramadol Hydrochloride Extended-Release Tablets affect you. Tramadol Hydrochloride Extended-Release 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 Tramadol Hydrochloride Extended-Release Tablets may cause you to overdose and die.

    The possible side effects of Tramadol Hydrochloride Extended-Release Tablets:

    constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, seizure. 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 Tramadol Hydrochloride Extended-Release 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.

    Rx Only

    Manufactured by:
    Par Pharmaceutical
    Chestnut Ridge, NY 10977

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

    10/2019 OS221A-01-50-14

  • Indications and Usage Section

    INDICATIONS AND USAGE

    Tramadol Hydrochloride Extended-Release Tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate.

    Limitations of Use

    Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS], reserve Tramadol Hydrochloride Extended-Release Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or immediate-release opioids], are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
    Tramadol Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.

  • Principal Display Panel

    Tramadol 200mg

  • INGREDIENTS AND APPEARANCE
    CONZIP 
    tramadol hcl 200mg tablet, film coated, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0101(NDC:10370-222)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE200 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code A222
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0101-260 in 1 BOTTLE; Type 0: Not a Combination Product06/27/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20049106/27/2012
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0101)