ORPHENADRINE CITRATE

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
ORPHENADRINE CITRATE
Generic name
ORPHENADRINE CITRATE
Manufacturer
REMEDYREPACK INC.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
7905e80f-b60b-48e8-8e63-a3e50211bfe4
SPL ID
508a41a9-403b-e409-e063-6294a90ad6fa
Version
3
Effective date
2026-04-28
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:28:38
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.