Norgesic Forte 770 mg/1
Orphenadrine Citrate, Aspirin and Caffeine · TABLET, MULTILAYER · Poly Pharmaceuticals, Inc.
Norgesic Forte is a tablet, multilayer containing orphenadrine citrate, aspirin and caffeine at 770 mg/1, taken oral. Manufactured by Poly Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Norgesic Forte
- Generic Name
- Orphenadrine Citrate, Aspirin and Caffeine
- NDC Code (Product)
50991-999- Manufacturer
- Poly Pharmaceuticals, Inc.
- Strength
- 770 mg/1
- Dosage Form
- TABLET, MULTILAYER
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075141
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
- Marketing Start
- 04/01/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Norgesic Forte 50 mg/770mg/60 mg Tablets are indicated in: 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. Norgesic Forte Tablets do not directly relax tense skeletal muscles in man.
Dosage & Administration
DOSAGE AND ADMINISTRATION Norgesic Forte Tablets: Adults 1/2 to 1 tablet 3 to 4 times daily.
Warnings
WARNINGS Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Norgesic Forte Tablets 50mg/770mg/60mg contain aspirin and therefore are not recommended for use in patients with chicken pox, influenza, or flu symptoms. Norgesic Forte 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. Aspirin should be used with extreme caution in the presence of peptic ulcers and coagulation abnormalities. Usage in Pregnancy Risk Summary Use of NSAIDs, including aspirin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Orphengesic Forte Tablets use between about 20 and 30 weeks of gestation, and avoid Orphengesic Forte Tablets use at about 30 weeks of gestation and later in pregnancy [see WARNINGS; Feta…
Contraindications
CONTRAINDICATIONS Because of the mild anti-cholinergic effect of orphenadrine, Norgesic Forte Tablets should not be used in patients with glaucoma, pyloric or duodenal obstruction, achalasia, prostatic hypertrophy, or obstructions at the bladder neck. Norgesic Forte Tablets 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.
Adverse Reactions
ADVERSE REACTIONS Side effects of Norgesic Forte Tablets are those seen with aspirin and caffeine or those usually associated with mild anticholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of Orphenadrine Citrate, Aspirin, and Caffeine Tablets has been reported. No causal relationship has been established. Rare G.I. hemorrhage due to aspirin content may be associated with the administration of Norgesic Forte Tablets. Some patients may experience transient episodes of lightheadedness, dizziness or syncope.
Frequently Asked Questions
What is Norgesic Forte used for?
Norgesic Forte contains Orphenadrine Citrate, Aspirin and Caffeine. It is a tablet, multilayer taken oral. Consult your doctor for specific uses.
Is Norgesic Forte a controlled substance?
Norgesic Forte is not classified as a controlled substance by the DEA.
What is the generic name for Norgesic Forte?
The generic name for Norgesic Forte is Orphenadrine Citrate, Aspirin and Caffeine. There are 4 other brand versions of Orphenadrine Citrate, Aspirin and Caffeine.
What is the NDC code for Norgesic Forte 770 mg/1?
The NDC (National Drug Code) for Norgesic Forte 770 mg/1 is 50991-999, listed by Poly Pharmaceuticals, Inc..