hydrocodone bitartrate 10 mg acetaminophen 300 mg

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require 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.

Tris Pharma Inc

FDA Reported Adverse Reactions
`[1] drug dependence` `[2] pain` `[3] overdose` `[4] emotional distress` `[5] drug ineffective` `[6] nausea` `[7] fatigue` `[8] anxiety` `[9] drug withdrawal syndrome` `[10] headache`

4 years ago

OVAL WHITE C116

4 years ago

C116 OVAL WHITE

HOW SUPPLIED Each tablet contains 5 mg of hydrocodone bitartrate and 300 mg of acetaminophen. They are available as white to off-white capsule-shaped tablets, bisected on one side and debossed on the other side with C 114. NDC 27808-114-01 Bottles of 100 NDC 27808-114-02 Bottles of 500 Each tablet contains 7.5 mg of hydrocodone bitartrate and 300 mg of acetaminophen. They are available as white to off-white capsule-shaped tablets, bisected on one side and debossed on the other side with C 115. NDC 27808-115-01 Bottles of 100 NDC 27808-115-02 Bottles of 500 Each tablet contains 10 mg of hydrocodone bitartrate and 300 mg of acetaminophen. They are available as white to off-white capsule-shaped tablets, bisected on one side and debossed on the other side with C 116. NDC 27808-116-01 Bottles of 100 NDC 27808-116-02 Bottles of 500 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Store

HYDROCODONE BITARTRATE AND ACETAMINOPHEN Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ]. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Contains a Schedule II controlled drug substance. Manufactured for: Tris Pharma, Inc. Monmouth Junction, NJ 08852 www.trispharma.com LB8451 Rev. 12 05/2024

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hydrocodone bitartrate and acetaminophen tablet

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