ORNI O TAB

1. All Details: Specifications
Active Pharmaceutical Ingredients: Ofloxacin IP and Ornidazole IP.
Dosage Form: Film-coated oral tablet.
Coloring Agents: Titanium Dioxide IP and Lake Sunset Yellow.
Storage Environment: Store below 25°C in a dry place. Protect from light. Keep out of reach of children.
Regulatory Classification: Schedule H Prescription Drug – Caution: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Additional Safety Warning: This drug may cause low blood sugar and mental health related side effects.
Batch Identification: 1404813
Date of Manufacture (MFG.): 09/2024
Date of Expiration (EXP.): 08/2026
Maximum Retail Price (M.R.P.): Rs. 132.00 per 10 Tablets (Inclusive of all taxes).
2. General Information
Brand: Orni-O (stylized as Orni™-O)
Name: Ofloxacin and Ornidazole Tablets IP
Quantity: Strip of 10 Tablets (indicated by “/10 T.”).
Type: Prescription Antimicrobial / Antibiotic and Antiprotozoal Combination.
Factor (Form Factor): Solid oral tablet (Film-coated).
Maximum Shelf Life: 23 months (From September 2024 to August 2026).
Food Preference: Not Applicable. Because this is a core pharmaceutical product, standard consumer dietary indicators(such as green or brown vegetarian markers) do not apply.
FSSAI: Not Applicable. This prescription therapeutic agent is governed under the Drugs and Cosmetics Act by the CDSCO, meaning it does not fall under the food regulations or licensing of the FSSAI (Food Safety and Standards Authority of India).
3. Product Details: Ingredients
Each film-coated tablet contains:
Ofloxacin IP: 200 mg
Ornidazole IP: 500 mg
Excipients: q. s. (Quantity Sufficient)
4. Directions: How to Use
Dosage: As directed by the Physician.
Administration: The tablet should be swallowed whole with water, preferably after a meal to help minimize potential stomach upset. It is critical to finish the full prescribed course of this antibiotic exactly as directed by your doctor, even if symptoms clear up early, to prevent the development of bacterial resistance. Do not crush, chew, or break the tablet.
5. Description
Orni-O is a broad-spectrum fixed-dose combination antimicrobial medication. It couples Ofloxacin (a fluoroquinolone antibiotic that inhibits bacterial DNA replication) with Ornidazole (a nitroimidazole antiprotozoal and antibacterial agent that disrupts microbial DNA structures). This dual-action mechanism makes it highly effective against mixed infections, particularly gastrointestinal infections like severe diarrhea, dysentery, pelvic inflammatory diseases, and certain dental or gynecological infections. The packaging includes a prominent red warning strip and an additional black box warning concerning blood sugar and mental health monitoring.
6. Manufacturer Information
Mkt. and Mfg. by: Zydus Healthcare Limited
Plant Address: (Unit II), 967 (P), 968 (P), 970 (P), Kumrek, Sikkim – 737132.
Manufacturing License Number (Mfg. Lic. No.): M/765/2016
Production Code reference: 2083451
7. Marketed By
Marketed by: Zydus Healthcare Limited