Misoprostol Tablets 100mcg Technical Specification:
| Product Name: | Misoprostol Tablets 100mcg |
| Brand Name: | Generic |
| Strength: | (100mcg), (200mcg) |
| 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: | Anti-Ulcer, Gastroenterological, Gynaecological |
| Indication: | Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Misoprostol Tablets 100mcg
- Misoprostol Tablets 200mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Misoprostol Tablets 100mcg
Each uncoated tablet contains:
Misoprostol USP…………………….100mcg
(As 1% HPMC Dispersion)
Excipients………………………………….q.s.
- Misoprostol Tablets 200mcg
Each uncoated tablet contains:
Misoprostol USP …………………….200mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
THERAPEUTIC INDICATIONS:
Misoprostol is used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Do not take it if you are pregnant and do not become pregnant while taking this medicine because it can cause miscarriage or other serious complications.
not for use in women of child bearing potential unless at high risk from NSAID THERAPY.
Warning: To be sold by retail on the prescription of a Gynecologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Misoprostol Tablets 100mcg
B) Misoprostol Tablets 200mcg
B) Misoprostol Tablets 200mcg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Misoprostol Tablets 100mcg
Each uncoated tablet contains:
Misoprostol USP…………………….100mcg
(As 1% HPMC Dispersion)
Excipients………………………………….q.s.
B) Misoprostol Tablets 200mcg
Each uncoated tablet contains:
Misoprostol USP …………………….200mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
Each uncoated tablet contains:
Misoprostol USP…………………….100mcg
(As 1% HPMC Dispersion)
Excipients………………………………….q.s.
B) Misoprostol Tablets 200mcg
Each uncoated tablet contains:
Misoprostol USP …………………….200mcg
(As 1% HPMC Dispersion)
Excipients………………………..q.s.
THERAPEUTIC INDICATIONS:
Misoprostol is used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
DO NOT TAKE IF YOU ARE PREGNANT AND DONOT BECOME PREGNANT WHILE TAKING THIS MEDICINE BECAUSE IT CAN CAUSE MISCARRIAGE OR OTHER SERIOUS COMPLICATIONS.
NOT FOR USE IN WOMEN OF CHILD BEARING POTENTIAL UNLESS AT HIGH RISK FROM NSAID THERAPY.
WARNING: To be sold by retail on the prescription of a Gynecologist only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
DO NOT TAKE IF YOU ARE PREGNANT AND DONOT BECOME PREGNANT WHILE TAKING THIS MEDICINE BECAUSE IT CAN CAUSE MISCARRIAGE OR OTHER SERIOUS COMPLICATIONS.
NOT FOR USE IN WOMEN OF CHILD BEARING POTENTIAL UNLESS AT HIGH RISK FROM NSAID THERAPY.
WARNING: To be sold by retail on the prescription of a Gynecologist only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container.
Dosage: As directed by the Physician
Dosage: As directed by the Physician
