Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets (10mg+10mg+2.5mg) Technical Specification:
| Product Name: | Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets |
| Brand Name: | Generic |
| Strength: | 10mg+10mg+2.5mg, 20mg+20mg+5mg |
| Dosage Form: | Tablet (Enteric Coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihistamine, Vitamin B6 |
| Indication: | To treat nausea and vomiting in pregnancy |
| Storage: | Store below 30°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets 10mg+10mg+2.5mg
Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets 20mg+20mg+5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Doxylamine Succinate, Pyridoxine Hydrochloride & Folic Acid Tablets 10mg+10mg+2.5mg
Each Enteric Coated Tablets Contains:
Doxylamine Succinate USP………………..10 mg
Pyridoxine Hydrochloride IP……………..10 mg
Folic Acid IP……………………………………….2.5 mg
Excipients……………………………………………Q.S.
Colour: Ferric Oxide Red USP-NF
Appropriate Overages of Vitamin are added to compensate the loss on storage.
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 & SCHEDULE:
CAUTION:
Keep out of reach of children.
Tablet should be swallowed whole and not chewed or crushed.
SCHEDULE: SCHEDULE G PRESCRIPTION DRUG: CAUTION: IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
STORAGE & DOSAGE:
STORAGE: Store protected from light and moisture at a temperature not exceeding to 30°C.
DOSAGE: As directed by the Physician.
INDICATION: For Nausea & Vomiting During Pregnancy.