GENERIC NAME OF THE MEDICINAL PRODUCT:

Hydroxyzine HCl Tablets USP 10mg
Hydroxyzine HCl Tablets USP 25mg
Hydroxyzine HCl Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Hydroxyzine HCl Tablets USP 10mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride …………...10mg
Excipients……………………………………... q.s
Colours: Titanium Dioxide

b) Hydroxyzine HCl Tablets USP 25mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride…………….25mg
Excipients………………………………………. q.s
Colours: Carmoisine Lake

c) Hydroxyzine HCl Tablets USP 50mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride…………….50mg
Excipients………………………………………. q.s
Colours: Red Iron Oxide

THERAPEUTIC INDICATIONS:

Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Hydroxyzine HCl Tablets USP Technical Specification:

Product Name:
 Hydroxyzine HCl Tablets USP
Brand Name: Hydroxyzine HCl
Strength: 10mg, 25mg, 50mg
Dosage Form: Tablet (Film-coated)
Route of Administration: Via oral Route
Packing: 100s, 500s, 1000s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-allergic, Antihistamine
Indication: Hydroxyzine is used to treat itching caused by allergies. It is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Hydroxyzine may also be used short-term to treat anxiety or to help you feel sleepy/relaxed before and after surgery.
Storage: Store at 20° to 25° C (68° to 77° F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxyzine HCl Tablets USP 10mg
  • Hydroxyzine HCl Tablets USP 25mg
  • Hydroxyzine HCl Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Hydroxyzine HCl Tablets USP 10mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride ……………10mg
Excipients……………………………………… q.s
Colours: Titanium Dioxide

 b) Hydroxyzine HCl Tablets USP 25mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride…………….25mg
Excipients………………………………………. q.s
Colours: Carmoisine Lake

c) Hydroxyzine HCl Tablets USP 50mg
Each film coated Tablet contains:
Hydroxyzine Hydrochloride…………….50mg
Excipients………………………………………. q.s
Colours: Red Iron Oxide

THERAPEUTIC INDICATIONS:

  • Hydroxyzine Hydrochloride is indicated to assist in the management of anxiety in adults. Hydroxyzine Hydrochloride is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
    Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature].
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.