ORPHENADRINE CITRATE ASPIRIN CAFFEINE- orphenadrine citrate, aspirin, caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

orphenadrine citrate (UNII: X0A40N8I4S) (orphenadrine - UNII:AL805O9OG9), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)

Available from:

Jerome Stevens Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. - The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. These products do not directly relax tense skeletal muscles in man. Because of the mild anticholinergic effect of orphenadrine, these products should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy or obstructions at the bladder neck. These products are also contraindicated in patients with myasthenia gravis and in patients known to be sensitive to aspirin or caffeine. The drug is contraindicated in patients who have demonstrated a previous hypersensitivity to the drug.

Product summary:

Regular tablets can be identified as a round, multi-layered tablet embossed JSP 554 on one side, and contains orphenadrine citrate (2-dimethylaminoethyl 2-methylbenzhydryl ether citrate) 25 mg, aspirin 385 mg, and caffeine 30 mg. Forte tablets are exactly twice the strength of the regular. They are identified by their scored capsule shape. Each multi-layered tablet is embossed JSP 555 on one side and contains orphenadrine citrate 50 mg, aspirin 770 mg, and caffeine 60 mg. Products also contain: lactose, starch, D&C yellow #10 and FD&C blue #1. Regular: Bottles of Forte: Bottles of Store below 30°C (86°F) Caution: Federal law prohibits dispensing without prescription. Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 03/21 MG # 11584

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ORPHENADRINE CITRATE ASPIRIN CAFFEINE- ORPHENADRINE CITRATE, ASPIRIN,
CAFFEINE TABLET
JEROME STEVENS PHARMACEUTICALS, INC.
----------
ORPHENADRINE
CITRATE
ASPIRIN
CAFFEINE
REGULAR AND
FORTE TABLETS
ACTIONS:
Orphenadrine citrate is a centrally acting (brain stem) compound which
in animals
selectively blocks facilitatory functions of the reticular formation.
Orphenadrine does not
produce myoneural block, nor does it affect crossed extensor reflexes.
Orphenadrine
prevents nicotine-induced convulsions but not those produced by
strychnine.
Chronic administration of the regular formula to dogs and rats has
revealed no drug-
related toxicity. No blood or urine changes were observed, nor were
there any
macroscopic or microscopic pathological changes detected. Extensive
experience with
combinations containing aspirin and caffeine has established them as
safe agents. The
addition of orphenadrine citrate does not alter the toxicity of
aspirin and caffeine.
The mode of therapeutic action of orphenadrine has not been clearly
identified, but may
be related to its analgesic properties. Orphenadrine citrate also
possesses
anticholinergic actions.
INDICATIONS:
1. Symptomatic relief of mild to moderate pain of acute
musculoskeletal disorders.
2. The orphenadrine component is indicated as an adjunct to rest,
physical therapy, and
other measures for the relief of discomfort associated with acute
painful
musculoskeletal conditions.
The mode of action of orphenadrine has not been clearly identified,
but may be related
to its analgesic properties. These products do not directly relax
tense skeletal muscles in
man.
CONTRAINDICATIONS:
Because of the mild anticholinergic effect of orphenadrine, these
products should not be
used in patients with glaucoma, pyloric or duodenal obstruction,
achalasia, prostatic
hypertrophy or obstructions at the bladder neck. These products are
also
contraindicated in patients with myasthenia gravis and in patients
known to be sensitive
to aspirin or caffeine.
The drug is contraindicated in patients who have