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Paradoxical reactions hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hci.

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Of those 38 cases22 involved patients aged 18 months to 2 years of ageand 7 resulted in deathSerious outcomesincluding deathdisabilitylife-threatening eventsand hospitalizationoccurred with all routes of administrationwhether oralrectal or intravenous injection.

Promethazine is an antihistamine and works by blocking a certain natural substancehistaminethat your body makes during an allergic reactionIts other effectssuch as anti-nauseacalmingpain reliefmay work by affecting other natural substancessuch as acetylcholineand by acting directly on certain parts of the brain.

Each tabletfor oral administrationcontains 25 mg or 50 mg of promethazine hydrochlorideIn addition each tablet contains the following inactive ingredientsdibasic calcium phosphatemagnesium stearatemicrocrystalline cellulosesodium starch glycolate and stearic acid.

This medication may rarely cause a very serious condition called neuroleptic malignant syndromeNMSGet medical help right away if you have any of the following symptomsfevermuscle stiffness/pain/tenderness/weaknesssevere tirednesssevere confusionsweatingfast/irregular heartbeatdark urinesigns of kidney problemssuch as change in the amount of urine

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