BOXED WARNING
id: 12328681-b947-483b-bfac-abc9775f7310
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
DESCRIPTION
id: 414db44e-fb5b-44e9-bdca-d896b3f095c4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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-17methylmorphinan-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 hydrocodone bitartrate and Acetaminophen tablet contains:
Hydrocodone Bitartrate, USP 2.5 mg
Acetaminophen, USP 325 mg
In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.
The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.
INDICATIONS AND USAGE
id: 52d69799-d16d-45e9-9e50-f54363f50d34
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
id: d246981b-bc80-43f5-9a7d-07a254e013ec
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.
ADVERSE REACTIONS
id: 6d90a561-b6dc-43c4-80b4-a0ffb837433d
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Central Nervous System: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, and mood changes.
Gastrointestinal System: Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation.
Genitourinary System: Ureteral spasm, spasm of vesical sphincters, and urinary retention have been reported with opiates.
Respiratory Depression: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory center (see OVERDOSAGE).
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the OVERDOSAGE section.
OVERDOSAGE
id: 902ea3c7-3c92-43be-8724-142616d6a4af
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
DOSAGE AND ADMINISTRATION
id: b4fabd31-812c-4142-877b-6e51f7c60761
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
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2.5 mg/325 mg
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The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. |
HOW SUPPLIED
id: 7e23e2fd-fe2e-47cc-ac90-32b429f4058e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Hydrocodone Bitartrate and Acetaminophen Tablets USP are available as:
2.5 mg/325 mg 2.5 mg hydrocodone bitartrate and 325 mg acetaminophen, capsule-
shaped, white tablets, debossed with 2171 on one side.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA
Distributed by:
Watson Pharma, Inc.Parsippany, NJ 07054 USA
Revised: August 2014
220986-1
Image of Label
id: 793b83b1-6f9c-401e-9d25-6c1ff9144f63
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
