| Product Name: | Clomiphene Citrate Tablet USP |
| Brand Name: | Generic |
| Strength: | 25mg, 50mg,100mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 20s, 30s, 50s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Gynaecological Product |
| Indication: | Clomiphene is used to induce ovulation (egg production) in women who do not produce ova (eggs) but wish to become pregnant (infertility). Clomiphene is in a class of medications called ovulatory stimulants. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released. |
| Storage: | Store at 20° to 25°C (68° to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Clomiphene Citrate Tablet USP 25mg
- Clomiphene Citrate Tablet USP 50mg
- Clomiphene Citrate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Clomiphene Citrate Tablet USP 25mg
Each Un-coated tablet contains:
Clomiphene Citrate USP …………………………25mg
Excipients……………………………………………..q.s.
Colour: Quinoline yellow WS - Clomiphene Citrate Tablet USP 50mg
Each Un-coated tablet contains:
Clomiphene Citrate USP …………………………50mg
Excipients……………………………………………..q.s.
Colour: Ponceau 4 R - Clomiphene Citrate Tablet USP 100mg
Each Un-coated tablet contains:
Clomiphene Citrate USP …………………………100mg
Excipients……………………………………………..q.s.
Colour: Ponceau 4 R
THERAPEUTIC INDICATIONS:
Clomiphene is used to induce ovulation (egg production) in women who do not produce ova (eggs) but wish to become pregnant (infertility). Clomiphene is in a class of medications called ovulatory stimulants. It works similarly to estrogen, a female hormone that causes eggs to develop in the ovaries and be released.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.Keep the 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: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician.