DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AND CAFFEINE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

DIHYDROCODEINE BITARTRATE

Samenstelling:

DIHYDROCODEINE BITARTRATE 32 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are indicated for the relief of moderate to moderately severe pain. This combination product is contraindicated in persons with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus. This combination product is subject to the provisions of the Controlled Substance Act, and has been placed in Schedule III. Dihydrocodeine can produce drug dependence of the codeine type and therefore has the potential of being abused. Like other opioid analgesics, dihydrocodeine may produce subjective effects other than analgesia (e.g., euphoria, relaxation), which may contribute to abuse by some patients. Psychological dependence, physical dependence, and tolerance may d

Product samenvatting:

Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine* bitartrate 32 mg (*Warning: May be habit-forming).  Tablets are white, oval-shaped single scored and are debossed “Boca” on one side and “611” on the other side; are supplied in Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container with a child-resistant closure. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Rx Only Manufactured for: Boca Pharmacal, Inc. Coral Springs, FL 33065 www.bocapharmacal.com Rev. 06/09 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DIHYDROCODEINE BITARTRATE, ACETAMINOPHEN AND CAFFEINE - DIHYDROCODEINE
BITARTRATE, ACETAMINOPHEN AND CAFFEINE TABLET
PHYSICIANS TOTAL CARE, INC.
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ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE TABLETS
DESCRIPTION
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets are
supplied in tablet form for oral
administration.
Each tablet contains:
Acetaminophen
712.8 mg
Caffeine
60 mg
Dihydrocodeine* bitartrate
32 mg
*Warning: May be habit forming
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
C H NO M.W.=151.16
Caffeine (1,3,7-trimethylxanthine), a bitter, white crystalline
powder, is a central nervous system
stimulant. It has the following structural formula:
C H N O M.W=194 .19
Dihydrocodeine Bitartrate
(4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine Bitartrate (4,5a-epoxy-
3-methoxy-17-methylmDihydrocodeine Bitartrate
(4,5a-epoxy-3-methoxy-17-methylmDihydrocodeine
Bitartrate (4,5a-epoxy-3-methoxy-17-methylmorphinan-6a-ol
(+)-tartrate), an odorless, fine white
powder is an opioid analgesic. It has the following structural
formula:
8
9
2
8
10
4
2
C H NO C H O M.W.=4 51.4 7
In addition, each tablet also contains the following inactive
ingredients: crospovidone, magnesium
stearate, microcrystalline cellulose, povidone, pregelatinized starch,
stearic acid.
CLINICAL PHARMACOLOGY:
Acetaminophen, caffeine, and dihydrocodeine bitartrate tablets contain
dihydrocodeine which 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.
This combination product also contains acetaminophen, a non-opiate,
non-salicylate analgesic and
antipyretic. This combination product contains caffeine as an
analgesic adjuvant. Caffeine is also a
central n