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In addition to requiring new labeling on these prescript"...
(hydrocodone bitartrate and acetaminophen) Tablet
- Patient Information:
Details with Side Effects
Hydrocodone bitartrate and acetaminophen are 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: 4,5 a-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Each Lorcet® 10/650 tablet for oral administration contains:
Hydrocodone Bitartrate...............................10 mg
WARNING: May be habit-forming.
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.
This product complies with 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...
Last reviewed on RxList: 7/25/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Lorcet Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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