1. All Details: Specifications
Active Pharmaceutical Ingredients: Thiocolchicoside, Aceclofenac, and Paracetamol.
Dosage Form: Film-coated tablet.
Coloring Agents: Red Iron Oxide and Titanium Dioxide IP.
Storage Environment: Store below 30°C in a dry, dark place. Protect from light and moisture. 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.
Clinical Warning: Warning: Taking Paracetamol more than daily dose may cause serious liver damage or allergic reactions (e.g., swelling of the face, mouth and throat, difficulty in breathing, itching or rash).
Batch Identification: B.No. TSTR 24001.
Date of Manufacture (MFG. DT.): JAN. 2024 (01/2024).
Date of Expiration (EXP. DT.): DEC. 2026 (12/2026).
Maximum Retail Price (M.R.P.): ₹ 258.00 per 10 Tablets (Inclusive of all taxes).
Manufacturing License Number (Mfg. Lic. No.): 08 13 2276.
2. General Information
Brand: TOLAGIN™ 4 (also printed in Devanagari script as टोलागीन ४).
Name: Thiocolchicoside, Aceclofenac and Paracetamol Tablets.
Quantity: Strip of 10 Tablets (indicated by “10 TABS.” on the stamped edge and pharmacy label).
Type: Prescription Combination Muscle Relaxant and Non-Steroidal Anti-Inflammatory Drug (NSAID).
Factor (Form Factor): Solid oral tablet (Film-coated).
Maximum Shelf Life: 35 months (From January 2024 to December 2026).
Food Preference: Not Applicable. As a potent prescription chemical formulation, standard consumer dietary symbols (like vegetarian green dots) are not present.
FSSAI: Not Applicable. This prescription medicine is strictly controlled under the Drugs and Cosmetics Act by the CDSCO. It is a therapeutic compound, not a dietary or health supplement, and therefore does not fall under the jurisdiction of the FSSAI (Food Safety and Standards Authority of India).
3. Product Details: Ingredients
Each film-coated tablet contains:
Thiocolchicoside: 4 mg
Aceclofenac IP: 100 mg
Paracetamol IP: 325 mg
4. Directions:
How to UseDosage: As directed by the Physician.
Administration Instructions: The tablet should be swallowed whole with a glass of water, typically taken after meals to minimize any potential stomach upset or gastric discomfort. Do not break, crush, or chew the tablet before swallowing to avoid disrupting the protective film coating. Do not exceed the prescribed dose or double doses due to the risk of severe liver toxicity associated with excessive Paracetamol intake.
5. Description
Tolagin 4 is a high-potency combination prescription tablet specifically formulated to treat painful muscle spasms associated with acute, severe musculoskeletal conditions such as lower back pain, muscle strains, sprains, and joint stiffness. It targets pain and muscle tension through three separate therapeutic pathways: Thiocolchicoside (a semi-synthetic muscle relaxant that works by interacting with the central nervous system to relieve muscle stiffness and spasms), Aceclofenac (an NSAID that inhibits cyclooxygenase enzymes to block the production of inflammatory chemicals), and Paracetamol (an analgesic and antipyretic agent that alters pain perception in the brain). The silver foil features a bright red Schedule H warning bar to mark its prescription-only status, alongside critical clinical warning texts outlining hepatotoxicity risks.
6. Manufacturer Information
Manufactured by: Maccur Laboratories (India) Pvt. Ltd. Plant Address: R.S. No. 243, Thiruvandarkoil Road, Chinnamapet, Villeanur, Puducherry – 605 110.
7. Marketed By
Marketed by: Pharmed Limited
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