"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
(hydrocodone bitartrate and acetaminophen) 10mg/325 mg, Tablets for Oral Administration
NORCO® (Hydrocodone bitartrate and acetaminophen) is supplied in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
Acetaminophen, 4´-hydroxy acetani lide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
NORCO®, for oral administration is available in the following strengths:
7.5 mg 325 mg
NORCO® 10/325 10 mg 325 mg
In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid; the 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake, the 10 mg/325 mg tablets include D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.
What are the possible side effects of acetaminophen and hydrocodone?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, fear, unusual thoughts or behavior;
- seizure (convulsions);
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...
What are the precautions when taking hydrocodone bitartrate and acetaminophen (Norco 5/325)?
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as hydromorphone, morphine, codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol,...
Last reviewed on RxList: 2/27/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Norco 5/325 Information
Norco 5/325 - User Reviews
Norco 5/325 User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Chronic Pain/Back Pain
Find tips and advances in treatment.