REGLAN ANI10 Pill — WHITE CAPSULE, 11mm — Metoclopramide

REGLAN pill photo
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ImprintREGLAN / ANI10
ColourWHITE
ShapeCAPSULE
Size11
StrengthMETOCLOPRAMIDE HYDROCHLORIDE 10 mg
Dosage formTablet
ManufacturerANI Pharmaceuticals, Inc.
NDC62559-166
Schedule—
AvailabilityPrescription only
IngredientsMETOCLOPRAMIDE HYDROCHLORIDE[METOCLOPRAMIDE]

What does this imprint mean?

The imprint "REGLAN ANI10" 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

Metoclopramide

Uses and warnings

BOXED WARNING: TARDIVE DYSKINESIA - Metoclopramide "can cause tardive dyskinesia (TD), a potentially irreversible, serious movement disorder." Risk increases "with duration of treatment and total cumulative dosage." The label states "metoclopramide is contraindicated in patients with a history of TD," limits treatment to a maximum of 12 weeks for GERD, and instructs to "immediately discontinue metoclopramide in patients who develop signs or symptoms of TD." Other major warnings include neuroleptic malignant syndrome, depression with suicidal ideation, and hypertensive crisis in patients with pheochromocytoma.

Indicated for "treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease in adults who fail to respond to conventional therapy" and for "relief of symptoms associated with acute and recurrent diabetic gastroparesis." Not recommended in pediatric patients because of increased risk of tardive dyskinesia, other extrapyramidal effects, and methemoglobinemia in neonates.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 06daee34-5164-4630-af92-bc43fa9c295d.xml