ASPIRIN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
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aspirin,
caffeine and
dihydrocodeine bitartrate capsule
Caraco Pharmaceutical Laboratories, Ltd
Each aspirin, caffeine, and dihydrocodeine bitartrate capsule, USP contains 356.4 mg aspirin, 30 mg caffeine, and 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habitforming).
The inactive ingredients present are alginic acid, cellulose, D&C Red 28, FD&C Blue 1, gelatin, iron oxides, stearic acid, and titanium dioxide.
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.
Aspirin, caffeine, and dihydrocodeine bitartrate capsule also contains the nonnarcotic antipyretic-analgesic, aspirin.
For the relief of moderate to moderately severe pain.
Hypersensitivity to dihydrocodeine, codeine, or aspirin.
Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities.
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.
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 aspirin, caffeine, and dihydrocodeine bitartrate capsule should be cautioned accordingly.
Patients receiving other narcotic analgesics, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with aspirin, caffeine, and dihydrocodeine bitartrate capsule may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
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.
Preparations containing aspirin should be kept out of the reach of children. Aspirin, caffeine, and dihydrocodeine bitartrate 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.
Aspirin, caffeine, and dihydrocodeine bitartrate capsule should be given with caution to certain patients, such as the elderly or debilitated.
The CNS-depressant effects of aspirin, caffeine, and dihydrocodeine bitartrate 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.
Clinical studies of aspirin, caffeine, and dihydrocodeine bitartrate 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.
The most frequently observed reactions include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, and skin reactions.
Dosage should be adjusted according to the severity of the pain and the response of the patient. Aspirin, caffeine, and dihydrocodeine bitartrate capsule is given orally. The usual adult dose is two capsules every 4 hours as needed for pain.
Aspirin, caffeine, and dihydrocodeine bitartrate capsules, USP are blue and gray, marked “CP” and “419”, supplied in:
Bottles of 100 capsules; NDC 57664-419-88
Store at room temperature, approx. 25°C (77°F).
Keep tightly closed.
Dispense in tight container.
NDC 57664-419-88
100 Capsules
CIII
Aspirin, Caffeine, and Dihydrocodeine Bitartrate Capsules, USP
Each capsule contains: 356.4 mg aspirin, 30 mg caffeine and 16 mg drocode (dihydrocodeine) bitartrate (Warning–may be habit-forming).
SEALED FOR YOUR PROTECTION
Rx Only
Caraco Pharmaceutical Laboratories, Ltd.
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ASPIRIN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA AUTHORIZED GENERIC | NDA011483 | 10/01/2023 | |
| Labeler - Caraco Pharmaceutical Laboratories, Ltd (146974886) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mikart, Inc | 030034847 | MANUFACTURE | |
