Hydroxyzine Hydrochloride 10 MG Oral Tablet
INDICATIONS AND USAGE 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 a premedication and following general anesthesia, hydroxyzine hydrochloride tablets may potentiate meperidine 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 hydrochloride tablets are 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 hydrochloride tablets 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.
Mylan Pharmaceuticals Inc.
ROUND BLUE M H10
M H10 ROUND BLUE
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HOW SUPPLIED Hydroxyzine Hydrochloride Tablets, USP are available containing 10 mg, 25 mg or 50 mg of hydroxyzine hydrochloride, USP. The 10 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H10 on the other side. They are available as follows: NDC 0378-2586-01 bottles of 100 tablets NDC 0378-2586-10 bottles of 1000 tablets The 25 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H25 on the other side. They are available as follows: NDC 0378-2587-01 bottles of 100 tablets NDC 0378-2587-10 bottles of 1000 tablets The 50 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and H50 on the other side. They are available as follows: NDC 0378-2588-01 bottles of 100 tablets NDC 0378-2588-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 10/2016 HYDZ:R7
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