GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each capsule contains:
Hydrochlorothiazide USP……………………12.5mg
Excipients…………………………………………..q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
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.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Protect from light and moisture and freezing.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Hydrochlorothiazide Capsules USP 12.5mg Technical Specification:
| Product Name: | Hydrochlorothiazide Capsules USP |
| Brand Name: | Generic |
| Strength: | (12.5mg) |
| Dosage Form: | Capsules |
| 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). Protect from light and moisture and freezing. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Hydrochlorothiazide Capsules USP 12.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Hydrochlorothiazide Capsules USP 12.5mg
Each capsule contains:
Hydrochlorothiazide USP……………………12.5mg
Excipients…………………………………………..q.s
Approved Colours are used in capsule shells.
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.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Protect from light and moisture and freezing.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
