INDICATIONS AND USAGE
HYDROCODONE is a semi-synthetic opioid synthesized from codeine, one of the opioid alkaloids found in the opium poppy. It is a narcotic analgesic used orally as an antitussive/cough suppressant, but also commonly taken orally for relief of moderate to severe pain.
HYDROCODONE bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
HYDROCODONE bitartrate and acetaminophen is supplied in tablet form for oral administration.
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.
DOSAGE AND ADMINISTRATION
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.
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 IT'S SUPPLIED
HYDROCODONE bitartrate and acetaminophen tablets, USP are available in the following strengths:
- 2.5 mg/500 mg
- 5 mg/500 mg
- 7.5 mg/325 mg
- 7.5 mg/500 mg
- 7.5 mg/650 mg
- 7.5 mg/750 mg
- 10 mg/325 mg
- 10 mg/500 mg
- 10 mg/650 mg
- 10 mg/660 mg
- 10 mg/750 mg
Store at controlled room temperature 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container with a child-resistant closure.