Doxylamine Succinate & Pyridoxine Hydrochloride Delayed-Release Tablets (20mg+20mg) Technical Specification:
| Product Name: | Doxylamine Succinate & Pyridoxine Hydrochloride Delayed-Release Tablets |
| Brand Name: | Generic |
| Strength: | (10mg+10mg), (20mg+20mg) |
| Dosage Form: | Tablet (Film Coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Antihistamine, Vitamin B6 |
| Indication: | To treat nausea and vomiting in pregnancy |
| Storage: | Store at 20°C to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Doxylamine Succinate & Pyridoxine Hydrochloride Delayed-Release Tablets (10mg+10mg)
Doxylamine Succinate & Pyridoxine Hydrochloride Delayed-Release Tablets (20mg+20mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Doxylamine Succinate & Pyridoxine Hydrochloride Delayed-Release Tablets
Each Film Coated Delayed-Release Tablets Contains:
Doxylamine Succinate USP………….…20 mg
Pyridoxine Hydrochloride USP……….20 mg
Excipients…………………………………..Q.S.
THERAPEUTIC INDICATIONS:
This combination is used to treat nausea and vomiting in pregnant women (also called morning sickness) whose symptoms have not been relieved by other treatments.
CAUTION & WARNING:
CAUTION:
Keep this and all medications out of reach of children.
Swallow the tablet whole. Do not crush, chew or split the tablet.
WARNING: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
STORAGE & DOSAGE:
STORAGE: Store at 20°C to 25°C (68°F to 77°F). Protect from moisture and light.
DOSAGE: As directed by the Physician.