Internal Analgesic
An OTC monograph, established by the FDA, outlines the conditions under which certain internal analgesic drugs are considered safe and effective for self-treatment. These drugs, like acetaminophen or aspirin, typically relieve pain and fever. The monograph dictates what ingredients are allowed, proper dosage, and necessary warnings on the label. This ensures consumers have access to safe and effective pain relief medications without a prescription, while also being informed of potential risks like stomach bleeding or allergic reactions.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Acetaminophen | M013.10 (Part 343) |
| Aspirin ingredients | M013.10 (Part 343) |
| Carbaspirin calcium | M013.10 (Part 343) |
| Choline salicylate | M013.10 (Part 343) |
| Magnesium salicylate | M013.10 (Part 343) |
| Sodium salicylate | M013.10 (Part 343) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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