Meperidine Hydrochloride 50 MG Oral Tablet Demerol
1 INDICATIONS AND USAGE DEMEROL Tablets and Oral Solution are indicated for the management of acute 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 and Precautions ( 5.2 ) ] , reserve DEMEROL Tablets or Oral Solution 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. DEMEROL Tablets and Oral Solution 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. DEMEROL Tablets or Oral Solution should not be used for the treatment of chronic pain. Use of DEMEROL Tablet or Oral Solution for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine. DEMEROL Tablets and Oral Solution are opioid agonists indicated for the management of pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve DEMEROL Tablets and Oral Solution 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 ( 1 ) Have not provided adequate analgesia, or are not expected to provide adequate analgesia ( 1 ) DEMEROL Tablets and Oral Solution 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. DEMEROL Tablets and Oral Solution should not be used for the treatment of chronic pain. Use of DEMEROL Tablets and Oral Solution for an extended period of time may increase the risk of toxicity (e.g., seizures) from the accumulation of the meperidine metabolite, normeperidine.
validus pharmaceuticals llc
ROUND WHITE W D 35
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Meperidine Hydrochloride 100 MG Oral Tablet Demerol
validus pharmaceuticals llc
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16 HOW SUPPLIED/STORAGE AND HANDLING DEMEROL (
MEPERIDINE HYDROCHLORIDE) Tablets 50 mg, are white, round, convex scored tablets debossed with “W” on one side and “D” over “35” on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-335-01) DEMEROL (
MEPERIDINE HYDROCHLORIDE) Tablets 100 mg, are white, round, convex scored Tablets debossed with “W” on one side and “D” over “37” on the other, and are supplied as: HDPE plastic bottles of 100 (NDC Number 30698-337-01) DEMEROL (
MEPERIDINE HYDROCHLORIDE) Oral Solution, 50mg per 5mL (10 mg/mL) is non-alcoholic, banana-flavored syrup, and is supplied in 16 fl. oz. bottles (NDC Number 30698-332-16). Store at 77°F (25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Store DEMEROL Tablets and Oral Solution securely and dispose of properly.
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