Orphenadrine Citrate label

Orphenadrine Citrate

Orphenadrine Citrate Recall

Get an alert when a recall is issued.

Side Effects & Adverse Reactions

Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine citrate extended-release tablets 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Orphenadrine citrate is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculo skeletal conditions. The mode of action of the drug has not been clearly identified, but may be related to its analgesic properties. Orphenadrine citrate does not directly relax tense skeletal muscles in man.

History

There is currently no drug history available for this drug.

Other Information

Orphenadrine citrate is the citrate salt of orphenadrine: (2-dimethyl-aminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol and has a molecular weight of 461.51. The molecular formula C18H23NO • C6H8O7 is represented by the following structural formula:

Chemical Structure

Each orphenadrine citrate extended-release tablet contains 100 mg orphenadrine citrate. Orphenadrine citrate extended-release tablets also contain: calcium stearate, ethylcellulose and lactose monohydrate.

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Orphenadrine Citrate Recall

Side Effects & Adverse Reactions

FDA Safety Alerts

Manufacturer Warnings

FDA Labeling Changes

Other Information

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Orphenadrine Citrate Manufacturers

Preferred Pharmaceuticals, Inc.
No Recall
Orphenadrine Citrate | Preferred Pharmaceuticals, Inc.
Adults-Two tablets per day; one in the morning and one in the evening.
Blenheim Pharmacal, Inc.
No Recall
Orphenadrine Citrate | Blenheim Pharmacal, Inc.
Adults

Two tablets per day; one in the morning and one in the evening.
Watson Laboratories, Inc.
No Recall
Orphenadrine Citrate | Watson Laboratories, Inc.
Adults: 2 mL (60 mg) intravenously or intramuscularly - May be repeated every 12 hours. Relief may be maintained by one (100 mg) orphenadrine citrate tablet twice daily.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Rebel Distributors Corp
No Recall
Orphenadrine Citrate | Rebel Distributors Corp
Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 25 mg/385 mg/30 mg: Adults 1 to 2 tablets 3 to 4 times daily.

Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 50 mg/770 mg/60 mg: Adults 1/2 to 1 tablet 3 to 4 times daily.
Stat Rx Usa Llc
No Recall
Orphenadrine Citrate | Stat Rx Usa Llc
TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.
Physicians Total Care, Inc.
No Recall
Orphenadrine Citrate | Physicians Total Care, Inc.
Adults
Two tablets per day; one in the morning and one in the evening.
H.j. Harkins Company, Inc.
No Recall
Orphenadrine Citrate | H.j. Harkins Company, Inc.
TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.
Preferred Pharmaceuticals, Inc
No Recall
Orphenadrine Citrate | Preferred Pharmaceuticals, Inc
Adults
Two tablets per day; one in the morning and one in the evening.
Sagent Pharmaceuticals
No Recall
Orphenadrine Citrate | Sagent Pharmaceuticals
INJECTION: Adults – One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
Pd-rx Pharmaceuticals, Inc.
No Recall
Orphenadrine Citrate | Pd-rx Pharmaceuticals, Inc.
Adults
Two tablets per day; one in the morning and one in the evening.
Lake Erie Medical Dba Quality Care Products Llc
No Recall
Orphenadrine Citrate | Lake Erie Medical Dba Quality Care Products Llc
Adults
Two tablets per day; one in the morning and one in the evening.
Eon Labs, Inc.
No Recall
Orphenadrine Citrate | Eon Labs, Inc.
Adults-Two tablets per day; one in the morning and one in the evening.
Preferred Pharmaceuticals, Inc
No Recall
Orphenadrine Citrate | Topco Associates Llc
• do not exceed the maximum recommended daily dose in a 24 hour period • shake well before use • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor • drink a full glass (8 oz) of liquid with each dose • for accurate dosing, use dose cup provided • mL = milliliter; TBSP = Tablespoon
adults and children 12 years and older

30 mL (2 TBSP) to 60 mL (4 TBSP)

children 6 to 11 years

15 mL (1 TBSP) to 30 mL (2 TBSP)

children under 6 years

ask a doctor
Rebel Distributors Corp
No Recall
Orphenadrine Citrate | Rebel Distributors Corp
Adults
Two tablets per day; one in the morning and one in the evening.
Stat Rx Usa Llc
No Recall
Orphenadrine Citrate | Stat Rx Usa Llc
TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.
Unit Dose Services
No Recall
Orphenadrine Citrate | Unit Dose Services
Adults
Two tablets per day; one in the morning and one in the evening.
Akorn, Inc.
No Recall
Orphenadrine Citrate | Akorn, Inc.
INJECTION: Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
Aidarex Pharmaceuticals Llc
No Recall
Orphenadrine Citrate | Aidarex Pharmaceuticals Llc
Adults
Two tablets per day; one in the morning and one in the evening.
Bryant Ranch Prepack
No Recall
Orphenadrine Citrate | Bryant Ranch Prepack
Adults
Two tablets per day; one in the morning and one in the evening.
Avkare, Inc.
No Recall
Orphenadrine Citrate | Avkare, Inc.
TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.
Lake Erie Medical Dba Quality Care Products Llc
No Recall
Orphenadrine Citrate | Lake Erie Medical Dba Quality Care Products Llc
Adults-Two tablets per day; one in the morning and one in the evening.
Gavis Pharmaceuticals, Llc
No Recall
Orphenadrine Citrate | Gavis Pharmaceuticals, Llc
Adults

Two tablets per day; one in the morning and one in the evening.
A-s Medication Solutions Llc
No Recall
Orphenadrine Citrate | A-s Medication Solutions Llc
Adults
Two tablets per day; one in the morning and one in the evening.
Dispensing Solutions, Inc.
No Recall
Orphenadrine Citrate | Dispensing Solutions, Inc.
Adults

Two tablets per day; one in the morning and one in the evening.
Clinical Solutions Wholesale
No Recall
Orphenadrine Citrate | Clinical Solutions Wholesale
Adults
Two tablets per day; one in the morning and one in the evening.
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
No Recall
Orphenadrine Citrate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.
TABLETS
Adults-Two tablets per day; one in the morning and one in the evening.
Eon Labs, Inc.
No Recall
Orphenadrine Citrate | Eon Labs, Inc.
Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 25 mg/385 mg/30 mg: Adults 1 to 2 tablets 3 to 4 times daily.

Orphenadrine Citrate, Aspirin, and Caffeine Tablets, 50 mg/770 mg/60 mg: Adults 1/2 to 1 tablet 3 to 4 times daily.
Direct Rx
No Recall
Orphenadrine Citrate | Direct Rx
Adults

Two tablets per day; one in the morning and one in the evening.
Pd-rx Pharmaceuticals, Inc.
No Recall
Orphenadrine Citrate | Pd-rx Pharmaceuticals, Inc.
Adults

Two tablets per day; one in the morning and one in the evening.
Carilion Materials Management
No Recall
Orphenadrine Citrate | Carilion Materials Management
Adults-Two tablets per day; one in the morning and one in the evening.
American Health Packaging
No Recall
Orphenadrine Citrate | American Health Packaging
TABLETS
Adults-Two tablets per day; one in the morning and one in the evening.