U 116 Pill — WHITE ROUND, 8mm — Topiramate
| Imprint | U / 116 |
|---|---|
| Colour | WHITE |
| Shape | ROUND |
| Size | 8 |
| Strength | TOPIRAMATE 50 mg |
| Dosage form | Tablet, Film Coated |
| Manufacturer | Unichem Pharmaceuticals (USA), Inc. |
| NDC | 29300-116 |
| Schedule | — |
| Availability | Prescription only |
| Ingredients | TOPIRAMATE[TOPIRAMATE] |
What does this imprint mean?
The imprint "U 116" 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
Topiramate
Uses and warnings
No boxed warning; contraindications are listed as "none." Major warnings include "acute myopia and secondary angle closure glaucoma," which can cause "permanent vision loss" if untreated; "fetal toxicity," as use "during pregnancy can cause cleft lip and/or cleft palate"; "metabolic acidosis" from decreased serum bicarbonate, which can be severe; the class-wide warning that "antiepileptic drugs increase the risk of suicidal thoughts or behavior"; and "oligohidrosis and hyperthermia," primarily reported in pediatric patients, requiring monitoring for decreased sweating and elevated body temperature.
Topiramate tablets are indicated for: - "Initial monotherapy" in patients ≥2 years with partial-onset or primary generalized tonic-clonic seizures - "Adjunctive therapy" in adults and pediatric patients 2-16 years with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome - "Prophylaxis of migraine headache" in adults
How to identify this pill
- • Check the imprint matches exactly: "U 116".
- • Confirm the colour (WHITE) and shape (ROUND).
- • Compare the size (8) 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 3dde2a69-dfc3-403b-9ebc-4144fcac8631.xml