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In addition to requiring new labeling on these prescript"...
(hydrocodone bitartrate (10 mg) and acetaminophen (300 mg) per 15 mL) Oral Solution
- Patient Information:
Details with Side Effects
Hydrocodone bitartrate and acetaminophen is supplied in liquid form for oral administration.
WARNING: May be habit-forming
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:
ZOLVIT™ (hydrocodone bitartrate and acetaminophen oral solution contains):
|Per 5 mL||Per 15 mL|
|Hydrocodone Bitartrate||3.33 mg||10 mg|
|Acetaminophen||100 mg||300 mg|
In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring.
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: 8/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Zolvit 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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