Levothyroxine Sodium Tablets IP 12.5mcg Technical Specification:

Product Name:Levothyroxine Sodium Tablets IP 12.5mg
Brand Name:Generic
Strength:(12.5mcg), (25mcg), (50mcg), (75mcg), (88mcg), (100mcg)
Dosage Form:Tablets (Uncoated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Hypothyroidism
Indication: Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism).
Storage:Store below 30°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levothyroxine Sodium Tablets IP 12.5mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….12.5mcg
    Excipients……………………………………………………………….q.s.
    Colours: Red oxide of iron
  • Levothyroxine Sodium Tablets IP 25mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….25mcg
    Excipients……………………………………………………………….q.s.
    Colours: Lake Sunset yellow FCF
  • Levothyroxine Sodium Tablets IP 50mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….50mcg
    Excipients……………………………………………………………….q.s.
    Colours: Quinoline yellow
  • Levothyroxine Sodium Tablets IP 75mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….75mcg
    Excipients……………………………………………………………….q.s.
    Colours: Lake of quinoline yellow
  • Levothyroxine Sodium Tablets IP 88mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….88mcg
    Excipients……………………………………………………………….q.s.
    Colours: Ferric oxide yellow
  • Levothyroxine Sodium Tablets IP 100mcg
    Each uncoated tablet contains:
    L-Thyroxine Sodium IP
    Equivalent to anhydrous L-Thyroxine Sodium……….100mcg
    Excipients……………………………………………………………….q.s.
    Colours: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism). The thyroid gland makes thyroid hormones which help to control energy levels and growth. Levothyroxine is taken to replace the missing thyroid hormone thyroxine.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
Replace Cap Tightly After Use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage:  Store below 25°C. Protect from Light and moisture.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levothyroxine Sodium Tablets IP 12.5mcg
B) Levothyroxine Sodium Tablets IP 25mcg
C) Levothyroxine Sodium Tablets IP 50mcg
D) Levothyroxine Sodium Tablets IP 75mcg
E) Levothyroxine Sodium Tablets IP 88mcg
F) Levothyroxine Sodium Tablets IP 100mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levothyroxine Sodium Tablets IP 12.5mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….12.5mcg
Excipients……………………………………………………………….q.s.
Colours: Red oxide of iron


B) Levothyroxine Sodium Tablets IP 25mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….25mcg
Excipients……………………………………………………………….q.s.
Colours: Lake Sunset yellow FCF

C) Levothyroxine Sodium Tablets IP 50mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….50mcg
Excipients……………………………………………………………….q.s.
Colours: Quinoline yellow

D) Levothyroxine Sodium Tablets IP 75mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….75mcg
Excipients……………………………………………………………….q.s.
Colours: Lake of quinoline yellow

E) Levothyroxine Sodium Tablets IP 88mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….88mcg
Excipients……………………………………………………………….q.s.
Colours: Ferric oxide yellow

F) Levothyroxine Sodium Tablets IP 100mcg
Each uncoated tablet contains:
L-Thyroxine Sodium IP
Equivalent to anhydrous L-Thyroxine Sodium……….100mcg
Excipients……………………………………………………………….q.s.
Colours: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Levothyroxine is a medicine used to treat an underactive thyroid gland (hypothyroidism). The thyroid gland makes thyroid hormones which help to control energy levels and growth. Levothyroxine is taken to replace the missing thyroid hormone thyroxine.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
Replace Cap Tightly After Use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from Light and moisture.
Dosage: As directed by the Physician