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Carbamazepine Extended-Release Tablets USP 200mg (Carbetol CR) Carbamazepine Extended-Release Tablets USP 200mg Carbamazepine Extended-Release Tablets USP 200mg Carbamazepine Extended-Release Tablets USP 200mg Carbamazepine Extended-Release Tablets USP 200mg Carbamazepine Extended-Release Tablets USP 200mg
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Carbamazepine Extended-Release Tablets USP 200mg Technical Specification:

Product Name:           Carbamazepine Extended-Release Tablets USP
Brand Name:Carbetol CR
Strength:100mg, 200mg, 300mg, 400mg
Dosage Form:Tablets (Film-Coated-Extended Release)
Route of Administration:Via oral Route
Packing: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: Anti-Epileptic, Antipsychotic, Anticonvulsant,
Indication: Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia)
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Carbamazepine Extended-Release Tablets USP 200mg (Carbetol CR)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Carbamazepine Extended-Release Tablets USP 200mg
    Each Extended-Release tablet contains:
    Carbamazepine USP……………….200mg
    Excipients……………………………. q.s.
    Colures: D&C Yellow 11

THERAPEUTIC INDICATIONS:

Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia).

CAUTION & WARNING:

CAUTION:  Read enclosed leaflet before use.
Keep 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 from moisture.
Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Carbamazepine Extended-Release Tablets USP 100mg (Carbetol CR)
B. Carbamazepine Extended-Release Tablets USP 200mg (Carbetol CR)
C. Carbamazepine Extended-Release Tablets USP 300mg (Carbetol CR)
D. Carbamazepine Extended-Release Tablets USP 400mg (Carbetol CR)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Carbamazepine Extended-Release Tablets USP 100mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………100mg
Excipients……………………………. q.s.
Colures: Yellow Iron Oxide

B. Carbamazepine Extended-Release Tablets USP 200mg
Each Extended-Release tablet contains:
Carbamazepine USP……………….200mg
Excipients……………………………. q.s.
Colures: D&C Yellow 11

C. Carbamazepine Extended-Release Tablets USP 300mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………300mg
Excipients……………………………. q.s.
Colures: Quinoline Yellow

D. Carbamazepine Extended-Release Tablets USP 400mg
Each Film-Coated Extended-Release tablet contains:
Carbamazepine USP…………………400mg
Excipients……………………………. q.s.
Colures: Orange 4

THERAPEUTIC INDICATIONS:

Carbamazepine is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP 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 from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.