Acetaminophen 325 MG Hydrocodone Bitartrate 5 MG Oral Tablet
INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets 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): • 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.
Epic Pharma, LLC
OVAL WHITE E111
E111 OVAL WHITE
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HOW SUPPLIED
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablets, USP are available in the following strengths:
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablets USP, 5 mg/325 mg contain hydrocodone bitartrate 5 mg and acetaminophen 325 mg. They are supplied as white with orange specks, capsule-shaped tablets de-bossed “Є111” on one side and bisected on the other side in bottles of 100 tablets, NDC 42806-111-01.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablets USP, 7.5 mg/325 mg contain hydrocodone bitartrate 7.5 mg and acetaminophen 325 mg. They are supplied as modified capsule-shaped orange tablets, de-bossed “Є112” on one side and bisected on the other side in bottles of 100 tablets, NDC 42806-112-01.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablets USP, 10 mg/325 mg contain hydrocodone bitartrate 10 mg and acetaminophen 325 mg. They are supplied as modified capsule-shaped yellow tablets, de-bossed “Є113” on one side and bisected on the other side in bottles of 100 tablets, NDC 42806-113-01. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. A Schedule II Controlled Drug Substance. DEA Order Form Required. Store
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS ; Information for Patients ]. Dispense with Medication Guide available at: www.epic-pharma.com/medguide/Hydrocodone-Bitartrate-Acetaminophen-Tablet.pdf Manufactured by: Epic Pharma, LLC Laurelton, NY 11413 Rev. 12-2023-00 MF111REV12/23 OE1329
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