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SIDE EFFECTS: Constipation, drowsiness, vision changes or dry mouth may occur. If any of these effects persist or worsen, notify your doctor. Unlikely to occur but report promptly: restlessness, muscle stiffness, weakness, difficulty speaking, loss of balance, mask- like facial expression, trembling or shaking, dizziness, lip smacking or other uncontrollable movements, difficulty urinating, skin rash/discoloration. Very unlikely to occur but report promptly: persistent sore throat or fever, unusual bleeding or bruising, stomach pain, yellowing of eyes or skin, dark urine, hot dry skin, vomiting. This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome).

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Promethazine oral should not be given to a child younger than 2 years old. Promethazine oral can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

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Excessive sedation may occur when promethazine is combined with other medications that depress the central nervous system (brain) and cause sedation. Such drugs include ethanol, barbiturates, anti-anxiety medications, sedatives, other phenothiazines, and narcotic pain medications.

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