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] fatigue [3] pain [4] nausea [5] dyspnoea [6] drug ineffective [7] diarrhoea [8] dizziness [9] headache [10] off label use
4 years ago
OVAL WHITE G 037
4 years ago
G 037 OVAL WHITE
HOW SUPPLIED Each tablet contains 5 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 035. NDC 27808-035-01 Bottles of 100 NDC 27808-035-02 Bottles of 500 NDC 27808-035-03 Bottles of 1000 Each tablet contains 7.5 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 036. NDC 27808-036-01 Bottles of 100 NDC 27808-036-02 Bottles of 500 NDC 27808-036-03 Bottles of 1000 Each tablet contains 10 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 037. NDC 27808-037-01 Bottles of 100 NDC 27808-037-02 Bottles of 500 NDC 27808-037-03 Bottles of 1000 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 by: Tris Pharma, Inc . Monmouth Junction, NJ 08852 www.trispharma.com LB8138 Rev. 14 11/2023
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