0398 Pill — WHITE ROUND, 11mm — Diclofenac

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Imprint0398
ColourWHITE
ShapeROUND
Size11
StrengthDICLOFENAC SODIUM 75 mg;MISOPROSTOL 0.2 mg
Dosage formTablet, Delayed Release
ManufacturerBryant Ranch Prepack
NDC63629-4970
Schedule—
Availability—
IngredientsDICLOFENAC SODIUM[DICLOFENAC];MISOPROSTOL[MISOPROSTOL]

What does this imprint mean?

The imprint "0398" 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."

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How to identify this pill

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 6dfe5eaa-959a-49ca-9a17-366ed52c3b8e.xml