Sleep Aid Maximum Strength Nighttime Recall
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Questions & Answers
Side Effects & Adverse Reactions
Keep out of reach of children.
It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.
As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
There is currently no drug history available for this drug.
Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2- hydroxyethoxy)-ethyl] piperazine dihydrochloride, with the following structure:
Each 5 mL (teaspoonful), for oral administration, contains 10 mg of hydroxyzine hydrochloride.
The inactive ingredients for the oral solution are alcohol 0.5% v/v, corn syrup, methylparaben, peppermint flavor, propylene glycol, purified water, sodium benzoate, and sucrose. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH when necessary.
Sleep Aid Maximum Strength Nighttime Manufacturers
Winco Foods, Llc
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