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hydrocodone bitartrate and acetaminophen tablet

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Rhodes Pharmaceuticals L.P.


3 years ago OVAL WHITE R P H10 325 hydrocodone bitartrate and acetaminophen tablet

OVAL WHITE R P H10 325

HOW SUPPLIED

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets, USP are supplied as follows: 5 mg/325 mg white to off-white, capsule shape with H5/325 on one side and R bisect P on the other side. Bottles of 100 NDC 42858-201-01 Bottles of 500 NDC 42858-201-50 Unit Dose Packages of 100 (10 tablets × 10 Cards) NDC 42858-201-10 7.5 mg/325 mg white to off-white, capsule shape with H7.5 over 325 on one side and R bisect P on the other side. Bottles of 100 NDC 42858-202-01 Unit Dose Packages of 100 (10 tablets × 10 Cards) NDC 42858-202-10 10 mg/325 mg white to off-white, capsule shape with H10/325 on one side and R bisect P on the other side. Bottles of 100 NDC 42858-203-01 Bottles of 500 NDC 42858-203-50 Bottles of 1000 NDC 42858-203-90 Unit Dose Packages of 100 (10 tablets × 10 Cards) NDC 42858-203-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS, Information for Patients/Caregivers ] .


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