0397 Pill — WHITE ROUND, 11mm — Diclofenac
| Imprint | 0397 |
|---|---|
| Colour | WHITE |
| Shape | ROUND |
| Size | 11 |
| Strength | DICLOFENAC SODIUM 50 mg;MISOPROSTOL 200 ug |
| Dosage form | Tablet, Delayed Release |
| Manufacturer | AvKARE, Inc. |
| NDC | 42291-232 |
| Schedule | — |
| Availability | Prescription only |
| Ingredients | DICLOFENAC SODIUM[DICLOFENAC];MISOPROSTOL[MISOPROSTOL] |
What does this imprint mean?
The imprint "0397" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.
Active ingredient
Diclofenac
Uses and warnings
BOXED WARNING: Cardiovascular Thrombotic Events - "NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal." Gastrointestinal Risk - "NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal." Contraindicated in patients with prior hypersensitivity, including those who "have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs." Additional warnings cover hepatic reactions - "elevations of one or more liver tests may occur" and "rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, have been reported."
Diclofenac sodium delayed-release tablets are indicated for "the acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis."
How to identify this pill
- • Check the imprint matches exactly: "0397".
- • Confirm the colour (WHITE) and shape (ROUND).
- • Compare the size (11) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 6324e226-ed28-6a3d-e053-2a91aa0a0dac.xml