GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Betahistine Dihydrochloride Tablet IP 8mg
B) Betahistine Dihydrochloride Tablet IP 16mg
C) Betahistine Dihydrochloride Tablet IP 24mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Betahistine Dihydrochloride Tablet IP 8mg
Each Film-coated tablet contains:
Betahistine Dihydrochloride IP.……….…….8mg
Excipients ………………………………………………. q.s
Colour: Titanium Dioxide IP

B) Betahistine Dihydrochloride Tablet IP 16mg
Each Film-coated tablet contains:
Betahistine Dihydrochloride IP.………..……..16mg
Excipients ……………………………………………….…..q.s
Colour: Red Oxide of Iron


C) Betahistine Dihydrochloride Tablet IP 24mg
Each Film-coated tablet contains:
Betahistine Dihydrochloride IP.………..……..24mg
Excipients ……………………………………………….…..q.s
Colour: Yellow Oxide of Iron

THERAPEUTIC INDICATIONS:

Betahistine is a histamine analogue medicine that is used to treat symptoms of Meniere’s syndrome such as dizziness (vertigo), ringing in the ears (tinnitus), loss of hearing and nausea. This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician.

Betahistine Dihydrochloride Tablet IP 16mg Technical Specification:

Product Name:Betahistine Dihydrochloride Tablet IP 16mg
Brand Name:BETHATAJ
Strength:8mg, 16mg, 24mg
Dosage Form:Tablets (Film coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti-histamine
Indication: Betahistine is a histamine analogue medicine that is used to treat symptoms of Meniere’s syndrome such as dizziness (vertigo), ringing in the ears (tinnitus), loss of hearing and nausea. This medicine works by improving blood flow in the inner ear. This lowers the build-up of pressure.
Storage:Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Betahistine Dihydrochloride Tablet IP 16mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Betahistine Dihydrochloride Tablet IP 16mg
    Each Film-coated tablet contains:
    Betahistine Dihydrochloride IP.……….…….16mg
    Excipients ………………………………………………. q.s
    Colour: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Betahistine is a histamine analogue medicine that is used to treat symptoms of Meniere’s syndrome such as dizziness (vertigo), ringing in the ears (tinnitus), loss of hearing and nausea. This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Read enclosed leaflet before use.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) Store in cool, dry & dark place Protect from Light & moisture.

Dosage: As directed by the Physician.