| Product Name: | Hydrochlorothiazide Tablets USP |
| Brand Name: | Generic |
| Strength: | (12.5mg), (25mg) |
| Dosage Form: | Tablets (uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihypertensive |
| Indication: | Hydrochlorothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
Hydrochlorothiazide Tablets USP 25mg Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Hydrochlorothiazide Tablets USP 12.5mg
- Hydrochlorothiazide Tablets USP 25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Hydrochlorothiazide Tablets USP 12.5mg
Each uncoated tablet contains:
Hydrochlorothiazide USP…………………12.5mg
Excipients……………………………………….q.s
Color: Sunset yellow FCF
B. Hydrochlorothiazide Tablets USP 25mg
Each uncoated tablet contains:
Hydrochlorothiazide USP…………………25mg
Excipients……………………………………….q.s
Color: Sunset Yellow
THERAPEUTIC INDICATIONS:
Hydrochlorothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER AS DEFINED IN THE USP USING A CHILD-RESISTANT CLOSURE.
KEEP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician