GENERIC NAME: Acetyl Salicylic Acid 400mg, codeine 15mg, caffeine 50mg

INDICATIONS: For relief of mild to moderate pain, fever and inflammation as in influenza, common cold, low back and neck pain, headache, trauma, following dental and surgical procedures.

DOSAGE:-Adults-1 or 2 tablets one to three times daily; Children's dosage, when recommendedby a physician: 10 to 14 years, one tablet, one to three times daily; 5 to 10 years, one-half tablet, one to three times daily.

CONTRAINDICATIONS: Gastrointestinal ulceration and sensitivity to any of the components.

WARNINGS: Salicylates increase the effects of anticoagulants. Caution is necessary when salicylates and anticoagulants are prescribed concurrently. Also, salicylates may depress the

concentration of prothrombin in the plasma. Large doses of salicylates may affect insulin

requirements of diabetics. Salicylates may potentiate sulfonylurea hypoglycemic agents.

Analgesic abuse (excessive and prolonged therapy) has been associated with nephropathy.

TO AVOID ACCIDENTAL POISONING ACETYLSALICYLIC ACID PREPARATIONS MUST BE KEPT WELL OUT OF REACH OF CHILDREN.

PRECAUTIONS: Give with caution to patients with asthma, other allergic conditions, bleeding

tendencies, or hypoprothrombinemia. Salicylates can produce changes in thyroid function tests.

Observe care in use of codeine, although tolerance and addiction are rare. Give codeine with caution to patients with severe respiratory depression. Its depressant effect may be enhanced by concurrent administration of sedatives and tranquilizers.

 ADVERSE REACTIONS: Acetylsalicylic acid: Gastrointestinal: dyspepsia, heartburn, nausea,

vomiting, diarrhea, gastrointestinal ulceration and bleeding. Ear reactions: tinnitus, hearing

loss. Hematologic: anemia, leukopenia, thrombocytopenia, purpura. Dermatologic and Hypersensitivity: urticaria, angioedema, pruritus, various skin eruptions, asthma and anaphylaxis.

Miscellaneous: mental confusion, drowsiness, sweating and thirst.

Codeine: Average or large doses may cause various gastrointestinal symptoms such as nausea, vomiting and constipation. Caffeine: May cause nausea, nervousness, insomnia, headache, vomiting, palpitation, vertigo, muscle tremor, sensory disturbances, excessive diuresis in sensitive patients. Large doses may cause gastric ulceration.

FULL INFORMATION AVAILABLE

ON REQUEST

HOW SUPPLIED

Tablets Specifications -White, scored,. Each tablet contains: acetylsalicylic acid 375 mg, caffeine citrate 30 mg, codeine phosphate 8 mg. Available in tubes of 12; bottles of 40, 100 and 250, also bottles of 60 with safety cap. Or As per customer. 

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed, light-resistant container.

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The products discussed herein may have different product labeling in different countries. The product information provided in this site is intended only for the residents of India.

                    
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