16 09 Pill — WHITE ROUND, 5mm — Baclofen

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Imprint16 / 09
ColourWHITE
ShapeROUND
Size5
StrengthBACLOFEN 5 mg
Dosage formTablet
ManufacturerCadila Healthcare Limited
NDC70771-1586
Schedule—
AvailabilityPrescription only
IngredientsBACLOFEN[BACLOFEN]

What does this imprint mean?

The imprint "16 09" 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

Baclofen

Uses and warnings

No boxed warning. A key warning concerns abrupt discontinuation: "Hallucinations and seizures have occurred on abrupt withdrawal of baclofen," so the dose should be reduced slowly when discontinuing. Caution is advised in patients with impaired renal function because baclofen is excreted largely unchanged by the kidney, and in patients who have had a stroke, who may show poor tolerability.

Indicated for "the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity," and in patients with spinal cord injuries or disease. The label notes it is "not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders" and has not been shown effective for spasticity due to stroke, cerebral palsy, or Parkinson's disease.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file f0cb651f-9235-4d82-a0f1-5987b7aaed10.xml