Tetracycline Hydrochloride Capsules USP 250mg Technical Specification:
| Product Name: | Tetracycline Hydrochloride Capsules USP 250mg |
| Brand Name: | Generic |
| Strength: | (250mg), (500mg) |
| Dosage Form: | Capsules (Hard Gelatin) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antibacterial, Antibiotics |
| Indication: | Tetracycline is an antibiotic that fights infection caused by bacteria. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Tetracycline Hydrochloride Capsules USP 250mg
- Tetracycline Hydrochloride Capsules USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tetracycline Hydrochloride Capsules USP 250mg
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….250mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
- Tetracycline Hydrochloride Capsules USP 500mg
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….500mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
THERAPEUTIC INDICATIONS:
Tetracycline is used to treat a wide variety of infections, including acne. It is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Tetracycline can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
THE USE OF DRUGS OF TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY & CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLOURATION OF THE TEETH (YELLOW-GREY-BROWN). TETRACYCLINE THEREFORE SHOULD NOT BE USED IN THE AGE GROUP UNLESS OTHER DRUGS ARE CONTRAINDICATED.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Tetracycline Hydrochloride Capsules USP 250mg
B) Tetracycline Hydrochloride Capsules USP 500mg
B) Tetracycline Hydrochloride Capsules USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Tetracycline Hydrochloride Capsules USP 250mg
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….250mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
B) Tetracycline Hydrochloride Capsules USP 500mg
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….500mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….250mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
B) Tetracycline Hydrochloride Capsules USP 500mg
Each hard gelatin capsule contains:
Tetracycline Hydrochloride USP………………….500mg
Excipients………………………………………………….q.s.
Approved colours are used in empty capsule shells.
THERAPEUTIC INDICATIONS:
Tetracycline is used to treat a wide variety of infections, including acne. It is an antibiotic that works by stopping the growth of bacteria. These antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Tetracycline can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
THE USE OF DRUGS OF TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY & CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLOURATION OF THE TEETH (YELLOW-GREY-BROWN). TETRACYCLINE THEREFORE SHOULD NOT BE USED IN THE AGE GROUP UNLESS OTHER DRUGS ARE CONTRAINDICATED.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
THE USE OF DRUGS OF TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY & CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLOURATION OF THE TEETH (YELLOW-GREY-BROWN). TETRACYCLINE THEREFORE SHOULD NOT BE USED IN THE AGE GROUP UNLESS OTHER DRUGS ARE CONTRAINDICATED.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).
Dosage: As directed by the Physician.
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).
Dosage: As directed by the Physician.
