Orphenadrine Citrate

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Orphenadrine Citrate Recall

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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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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

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Manufacturer Warnings

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

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FDA Labeling Changes

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

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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.

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History

There is currently no drug history available for this drug.

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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:

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

Sources

Orphenadrine Citrate Manufacturers

Preferred Pharmaceuticals, Inc.

Orphenadrine Citrate | Preferred Pharmaceuticals, Inc.

Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Blenheim Pharmacal, Inc.

Orphenadrine Citrate | Blenheim Pharmacal, Inc.

Adults

Two tablets per day; one in the morning and one in the evening.

No Recall
Watson Laboratories, Inc.

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.

No Recall
Rebel Distributors Corp

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.

No Recall
Stat Rx Usa Llc

Orphenadrine Citrate | Stat Rx Usa Llc

TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Physicians Total Care, Inc.

Orphenadrine Citrate | Physicians Total Care, Inc.

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
H.j. Harkins Company, Inc.

Orphenadrine Citrate | H.j. Harkins Company, Inc.

TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Preferred Pharmaceuticals, Inc

Orphenadrine Citrate | Preferred Pharmaceuticals, Inc

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Sagent Pharmaceuticals

Orphenadrine Citrate | Sagent Pharmaceuticals

INJECTION: Adults – One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

No Recall
Pd-rx Pharmaceuticals, Inc.

Orphenadrine Citrate | Pd-rx Pharmaceuticals, Inc.

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Orphenadrine Citrate | Lake Erie Medical Dba Quality Care Products Llc

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Eon Labs, Inc.

Orphenadrine Citrate | Eon Labs, Inc.

Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Preferred Pharmaceuticals, Inc

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

No Recall
Rebel Distributors Corp

Orphenadrine Citrate | Rebel Distributors Corp

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Stat Rx Usa Llc

Orphenadrine Citrate | Stat Rx Usa Llc

TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Unit Dose Services

Orphenadrine Citrate | Unit Dose Services

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Akorn, Inc.

Orphenadrine Citrate | Akorn, Inc.

INJECTION: Adults - One 2 mL vial (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.

No Recall
Aidarex Pharmaceuticals Llc

Orphenadrine Citrate | Aidarex Pharmaceuticals Llc

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Bryant Ranch Prepack

Orphenadrine Citrate | Bryant Ranch Prepack

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Avkare, Inc.

Orphenadrine Citrate | Avkare, Inc.

TABLETS: Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Lake Erie Medical Dba Quality Care Products Llc

Orphenadrine Citrate | Lake Erie Medical Dba Quality Care Products Llc

Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Gavis Pharmaceuticals, Llc

Orphenadrine Citrate | Gavis Pharmaceuticals, Llc

Adults

Two tablets per day; one in the morning and one in the evening.

No Recall
A-s Medication Solutions Llc

Orphenadrine Citrate | A-s Medication Solutions Llc

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Dispensing Solutions, Inc.

Orphenadrine Citrate | Dispensing Solutions, Inc.

Adults

Two tablets per day; one in the morning and one in the evening.

No Recall
Clinical Solutions Wholesale

Orphenadrine Citrate | Clinical Solutions Wholesale

Adults
Two tablets per day; one in the morning and one in the evening.

No Recall
Global Pharmaceuticals, Division Of Impax Laboratories Inc.

Orphenadrine Citrate | Global Pharmaceuticals, Division Of Impax Laboratories Inc.

TABLETS
Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
Eon Labs, Inc.

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.

No Recall
Direct Rx

Orphenadrine Citrate | Direct Rx

Adults

Two tablets per day; one in the morning and one in the evening.

No Recall
Pd-rx Pharmaceuticals, Inc.

Orphenadrine Citrate | Pd-rx Pharmaceuticals, Inc.

Adults

Two tablets per day; one in the morning and one in the evening.

No Recall
Carilion Materials Management

Orphenadrine Citrate | Carilion Materials Management

Adults-Two tablets per day; one in the morning and one in the evening.

No Recall
American Health Packaging

Orphenadrine Citrate | American Health Packaging

TABLETS
Adults-Two tablets per day; one in the morning and one in the evening.

No Recall