ATMEKSI

5 WARNINGS AND PRECAUTIONS ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol ( 5.1 ) ATMEKSI may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle ( 5.2 ) 5.1 CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. Patients receiving ATMEKSI (methocarbamol) Oral Suspension should be cautioned about combined effects with alcohol and other CNS depressants [ see Drug Interactions (7.1) ]. 5.2 Use in Activities Requiring Mental Alertness ATMEKSI may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

5.1 CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. Patients receiving ATMEKSI (methocarbamol) Oral Suspension should be cautioned about combined effects with alcohol and other CNS depressants [ see Drug Interactions (7.1) ].

5.2 Use in Activities Requiring Mental Alertness ATMEKSI may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

6 ADVERSE REACTIONS The following serious adverse reaction is described elsewhere in the labeling: Interactions with CNS Depressants and Alcohol [ see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of methocarbamol have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported with the administration of methocarbamol include: Body as a whole : Anaphylactic reaction, angioneurotic edema, fever, headache. Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis. Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting. Hemic and lymphatic system: Leukopenia. Immune System: Hypersensitivity reactions. Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo. Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria. Body: Anaphylactic reaction, angioneurotic edema, fever, headache ( 6 ) Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis ( 6 ) Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting ( 6 ) Hemic and lymphatic system: Leukopenia ( 6 ) Immune system: Hypersensitivity reactions ( 6 ) Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo ( 6 ) Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash and urticaria ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rosemont Pharmaceuticals, LLC. at 1-844-638-2235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .