Oxycodone and Acetaminophen
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bbbc5dc1-5a91-4430-adcb-a5f6963cc0a2
HUMAN PRESCRIPTION DRUG LABEL
Jan 23, 2023
Quality Care Products, LLC
DUNS: 831276758
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Oxycodone and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the- clock schedule. Oxycodone and Acetaminophen Tablets are given orally.
Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg; Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
|
Strength |
Maximal Daily Dose |
|
Oxycodone and Acetaminophen Tablets, USP, 7.5 mg/325 mg |
8 Tablets |
|
Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg |
6 Tablets |
Cessation of Therapy
In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.