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In addition to requiring new labeling on these prescript"...
(hydrocodone bitartrate and acetaminophen) Tablets, USP 7.5 mg/500 mg
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:
C18H21NO3•C4H606 • 2 ½ H20 M.W. 494.490
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:
C8H9NO2 M.W. 151.16
Each Lortab 7.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablet contains:
Hydrocodone Bitartrate.............................................7.5 mg
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and sugar spheres which are composed of starch derived from corn, sucrose, FD&C Blue #1 and D&C Yellow #10. 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...
Last reviewed on RxList: 1/30/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Lortab 7.5 Information
Report Problems to the Food and Drug Administration
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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