Orphenadrine Citrate, Aspirin and Caffeine
Orphenadrine Citrate, Aspirin and Caffeine tablets 50 mg/ 770 mg/ 60 mg USP
7776aae6-3cbd-4aed-9aac-4bed80339e27
HUMAN PRESCRIPTION DRUG LABEL
Jun 19, 2023
Atland Pharmaceuticals, LLC
DUNS: 080942150
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orphenadrine Citrate, Aspirin and Caffeine
PRODUCT DETAILS
INGREDIENTS (12)
Drug Labeling Information
PRECAUTIONS SECTION
PRECAUTIONS
Confusion, anxiety and tremors have been reported in a few patients receiving propoxyphene and orphenadrine concomitantly. As these symptoms may be simply due to an additive effect, reduction of dosage and/or discontinuation of one or both agents is recommended in such cases.
Safety of continuous long term therapy with Orphenadrine Citrate, Aspirin and Caffeine Tablets has not been established; therefore, if Orphenadrine Citrate, Aspirin and Caffeine Tablets are prescribed for prolonged use, periodic monitoring of blood, urine and liver function values is recommended.
Pregnancy
Embryo-Fetal Toxicity
Inform pregnant women to avoid use of aspirin and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with Orphenadrine Citrate, Aspirin and Caffeine Tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [ see WARNINGS; Fetal Toxicity, PRECAUTIONS; Pregnancy] .
Serious Skin Reactions, including DRESS
Advise patients to stop taking Orphenadrine Citrate, Aspirin and Caffeine Tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [ see Warnings].