{"adverse_reactions":["ADVERSE REACTIONS The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Dihydrocodeine is a semisynthetic narcotic analgesic, related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth-muscle components. The principal action of therapeutic value is analgesia. The capsule also contains the nonnarcotic antipyretic-analgesic, aspirin."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to dihydrocodeine, codeine, or aspirin."],"description":["DESCRIPTION Each capsule contains 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine. The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Dosage should be adjusted according to the severity of the pain and the response of the patient. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is given orally. The usual adult dose is two capsules every 4 hours as need­ed for pain."],"drug_interactions":["Drug Interactions The CNS-depressant effects of the dihydrocodeine bitartrate, aspirin, and caffeine capsule may be additive with that of other CNS depressants. See “ WARNINGS .” Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents."],"effective_time":"20130114","geriatric_use":["Geriatric Use Clinical studies of the dihydrocodeine bitartrate, aspirin, and caffeine capsule did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED Dihydrocodeine bitartrate, aspirin, and caffeine Capsules are blue and gray, marked “CP” and “419”, supplied in: Bottles of 100 capsules; NDC 57902-419-88 Store at room temperature, approx. 25°C (77°F). Keep tightly closed. Dispense in tight container. Manufactured for and distributed by: EUSA Pharma (USA), Inc. One Summit Square, Suite 201 1717 Langhorne Newtown Rd. Langhorne, PA 19047 www.eusapharma.com"],"id":"571b157e-3198-4533-9b05-cf31bc1dbab9","indications_and_usage":["INDICATIONS AND USAGE For the relief of moderate to moderately severe pain."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 57902-419-88 100 Capsules Dihydrocodeine bitartrate, aspirin, and caffeine capsules Each capsule contains: 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming), 356.4 mg aspirin, and 30 mg caffeine. SEALED FOR YOUR PROTECTION Rx Only EUSA Pharma (USA), Inc. Principal Display Panel"],"precautions":["PRECAUTIONS The dihydrocodeine bitartrate, aspirin, and caffeine capsule should be given with caution to certain patients, such as the elderly or debilitated. Drug Interactions The CNS-depressant effects of the dihydrocodeine bitartrate, aspirin, and caffeine capsule may be additive with that of other CNS depressants. See “ WARNINGS .” Aspirin may enhance the effects of anticoagulants and inhibit the uricosuric effects of uricosuric agents. Geriatric Use Clinical studies of the dihydrocodeine bitartrate, aspirin, and caffeine capsule did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"set_id":"2a2cd779-1c3e-445f-aa96-d02f9d4d91b7","spl_product_data_elements":["dihydrocodeine bitartrate and aspirin and caffeine DC dihydrocodeine bitartrate and aspirin and caffeine DIHYDROCODEINE BITARTRATE DIHYDROCODEINE ASPIRIN ASPIRIN CAFFEINE CAFFEINE ALGINIC ACID POWDERED CELLULOSE D&C RED NO. 28 FD&C BLUE NO. 1 GELATIN FERROSOFERRIC OXIDE STEARIC ACID TITANIUM DIOXIDE CP;419"],"version":"8","warnings":["WARNINGS Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. Drug Dependence Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of dihydrocodeine, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, dihydrocodeine is subject to the provisions of the Federal Controlled Substances Act. Usage in Ambulatory Patients Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient using the dihydrocodeine bitartrate, aspirin, and caffeine capsule should be cautioned accordingly. Interactions with other Central Nervous System Depressants Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with the dihydrocodeine bitartrate, aspirin, and caffeine capsule may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Usage in Pregnancy Reproduction studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males and females or has a teratogenic potential or other adverse effect on the fetus. Usage in Children Preparations containing aspirin should be kept out of the reach of children. The dihydrocodeine bitartrate, aspirin, and caffeine capsule is not recommended for patients 12 years of age and under. Since there is no experience in chil­dren who have received this drug, safety and efficacy in children have not been established."]}