Methadone Hydrochloride 40 MG Tablet for Oral Suspension Methadose
1 INDICATIONS AND USAGE Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration ( 2.1 )] . Methadone hydrochloride tablets for oral suspension are an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). ( 1 ) Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. ( 1 ) Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8. ( 1 , 2.1 )
SpecGx LLC
ROUND WHITE METHADOSE 40
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16 HOW SUPPLIED/STORAGE AND HANDLING METHADOSE ™ Dispersible Tablets, 40 mg: Available as a white, round tablet, debossed with “METHADOSE 40” on one side, a quadrisect on the other. Bottles of 100……NDC 0406-0540-34
METHADONE HYDROCHLORIDE Tablets for Oral Suspension, USP (Dispersible, orange Flavored), 40 mg: Available as a speckled orange colored, rounded rectangular tablet, debossed with “M” over “2540” on one side, a quadrisect on the other with an orange odor. Bottles of 100……NDC 0406-2540-01
METHADONE HYDROCHLORIDE tablets for oral suspension, if dispensed, must be packaged in child-resistant containers. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
METHADONE HYDROCHLORIDE tablets for oral suspension securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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