Drug Catalog - Product Detail
HYDROXYZINE HCL SYRUP USP SYR 10MG/5ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 54838-0502-80 | SILARX | 473 | 10MG/5ML | SYRUP |
PACKAGE FILES
Generic Name
HYDROXYZINE HYDROCHLORIDE
Substance Name
HYDROXYZINE DIHYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA201674
Description
DESCRIPTION Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-( p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Inert ingredients: citric acid, peppermint flavor, sodium benzoate, sucrose and water. Citric acid and/or sodium citrate may be used to adjust the pH when necessary. molec-struc
How Supplied
HOW SUPPLIED Hydroxyzine Hydrochloride Syrup (Hydroxyzine Hydrochloride Oral Solution, USP) 10 mg per 5 mL (teaspoonful) is a slightly yellow peppermint flavored liquid, supplied in 473 mL (16 fl. oz.) plastic bottles. NDC 54838-502-80 Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP controlled room temperature]. Dispense in a tight, light-resistant container with child-resistant closure as defined in the USP. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 10-1114 Rev. 01/23
Indications & Usage
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 in 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg four times daily.: children under 6 years, 50 mg daily in divided doses: children over 6 years: 50 to 100 mg daily in divided doses. For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg three times to four times daily.; children under 6 years, 50 mg daily in divided doses and children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all medications, the dosage should be adjusted according to the patient’s response to therapy.