Hydroxyzine Hydrochloride 25 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 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 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.

Heritage Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] fatigue` `[2] dyspnoea` `[3] nausea` `[4] diarrhoea` `[5] dizziness` `[6] drug ineffective` `[7] headache` `[8] asthenia` `[9] fall` `[10] pain`

5 years ago

ROUND WHITE H 106

HOW SUPPLIED HydrOXYzine Hydrochloride Tablets, USP, 10 mg - round, white, film-coated tablet, debossed “H/105”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-105-01 Bottles of 500 NDC 23155-105-05 Bottles of 1000 NDC 23155-105-10 25 mg - round, white, film-coated tablet, debossed “H/106”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-106-01 Bottles of 500 NDC 23155-106-05 Bottles of 1000 NDC 23155-106-10 50 mg- round, white, film-coated tablet, debossed “H/107”, supplied in bottles of 100, 500, and 1000. Bottles of 100 NDC 23155-107-01 Bottles of 500 NDC 23155-107-05 Bottles of 1000 NDC 23155-107-10 Dispense in a tight container as defined in the USP. Store at controlled room temperature 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 1-866-901-DRUG (3784) Iss.06/14

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