IRONSHORE 100mg Pill — BLUE;WHITE CAPSULE, 23mm — Methylphenidate

IRONSHORE pill photo
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ImprintIRONSHORE / 100mg
ColourBLUE;WHITE
ShapeCAPSULE
Size23
StrengthMethylphenidate Hydrochloride 100 mg
Dosage formCapsule
ManufacturerIronshore Pharmaceuticals, Inc.
NDC71376-205
ScheduleCII
AvailabilityPrescription only
IngredientsMethylphenidate Hydrochloride[Methylphenidate]

What does this imprint mean?

The imprint "IRONSHORE 100mg" 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

Methylphenidate

Uses and warnings

No boxed warning in this label, but strong warnings and contraindications are present. Contraindicated in patients with "marked anxiety, tension, and agitation" (symptoms may be aggravated), in glaucoma, in patients with motor tics or a family history of Tourette's syndrome, and with current or recent (within 14 days) MAOI use. Major warnings include sudden death and serious cardiovascular adverse events in patients with structural cardiac abnormalities or other serious heart problems; "stroke, and myocardial infarction have been reported in adults"; new or worsened psychiatric symptoms including psychosis and mania; and "temporary slowing in growth rate" in children with long-term use. It is a Schedule II controlled substance with high abuse and dependence potential.

Methylphenidate hydrochloride tablets are indicated for treatment of Attention-Deficit Hyperactivity Disorder, used as part of a comprehensive treatment program for children exhibiting "moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity," and for treatment of "narcolepsy" in adults.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file de387792-5329-447f-8ad3-968f6898d04b.xml