| Product Name: | Betahistine Dihydrochloride Tablets USP |
| Brand Name: | Generics |
| Strength: | 8mg, 16mg, 24mg, 32mg, 48mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s, 1000s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihistamine, Ear, Nose, and oropharynx |
| Indication: | The tablet can be divided into two equal halves. Betahistine is indicated for the treatment of Ménière’s syndrome, symptoms of which may include vertigo, tinnitus, hearing loss, and nausea. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Betahistine Dihydrochloride Tablets USP 8mg
- Betahistine Dihydrochloride Tablets USP 16mg
- Betahistine Dihydrochloride Tablets USP 24mg
- Betahistine Dihydrochloride Tablets USP 32mg
- Betahistine Dihydrochloride Tablets USP 48mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Betahistine Dihydrochloride Tablets USP 8mg
Each Film-coated tablet contains:
Betahistine dihydrochloride……………….8mg
Excipient……………………………………q. s.
Colors: Titanium Dioxide. - Betahistine Dihydrochloride Tablets USP 16mg
Each Film-coated tablet contains:
Betahistine dihydrochloride……………….16mg
Excipient……………………………………q. s.
Colors: Orange G. - Betahistine Dihydrochloride Tablets USP 24mg
Each Film-coated tablet contains:
Betahistine dihydrochloride……………….24mg
Excipient……………………………………q. s.
Colors: Orange II. - Betahistine Dihydrochloride Tablets USP 32mg
Each Film-coated tablet contains:
Betahistine dihydrochloride……………….32mg
Excipient……………………………………q. s.
Colors: Iron oxide. - Betahistine Dihydrochloride Tablets USP 48mg
Each Film-coated tablet contains:
Betahistine dihydrochloride……………….48mg
Excipient……………………………………q. s.
Colors: Carnosine Lake
THERAPEUTIC INDICATIONS:
Betahistine is a type of medicine called a “histamine analog”. betahistine is used for: ménière’s disease – the signs of this include: feeling dizzy (vertigo), ringing in the ears (tinnitus), hearing loss, or hearing difficulty this medicine works by improving blood flow in the inner ear. this lowers the buildup of pressure.
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 below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.