Citramon
FDA Label NDC 16638-118

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Borisovskiy Zavod Medicinskikh Preparatov Jsc for the product Citramon (NDC 16638-118). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Purpose

Analgetic - antipyretic

Uses

Effective in mild to moderate intensity pain (including headache, migraine, toothache, pain in osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, myalgia) and fever syndrome in acute infectious, infectious inflammatory diseases.

Warnings

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Prompt medical attention is critical even if you do not notice any signs or symptons.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center immediately.

Directions

Adults and children over 15 years take 1 tablet 2 - 3 times a day. The interval between the drug intakes should be at least 6 - 8 hours. Maximum single dose is 2 tablets, maximum daily dose is 4 tablets.

Other Information

Keep in a dry place at temperature below 77 °F (25 °C).

Inactive Ingredients

Cocoa, Citric acid monohydrate, Potato starch, Talc, Stearic acid.

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