THERACODOPHEN-LOW-90- hydrocodone bitartrate, acetaminophen, .gamma.-aminobutyric acid kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Διαθέσιμο από:

Physician Therapeutics LLC

INN (Διεθνής Όνομα):

HYDROCODONE BITARTRATE

Σύνθεση:

HYDROCODONE BITARTRATE 5 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Hydrocodone and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. Controlled Substance: Hydrocodone Bitartrate and Acetaminophen Tablets are classified as a Schedule III controlled substance. Abuse and Dependence: Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets are used for a short time for the treatment of pain. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce

Περίληψη προϊόντος:

Hydrocodone Bitartrate and Acetominophen Tablets USP are available in the following strengths: 2.5 mg/500 mg      2.5 mg hydrocodone bitartrate and 500 mg acetaminophen,  oblong, white tablets bisected on one side and debossed  with WATSON 388 on the other side, supplied in bottles of  100. How Supplied Theramine is supplied in purple and white, size 0 capsules in bottles of 60 or 90 capsules.

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

THERACODOPHEN-LOW-90 - HYDROCODONE BITARTRATE, ACETAMINOPHEN, .GAMMA.-
AMINOBUTYRIC ACID
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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THERACODOPHEN-LOW-90
NDC 53746-111-05
Hydrocodone
Bitartrate and
Acetominophen
Tablets, USP
Multiple Strengths:
Do not dispense unless
strength is stated.
Rx only 500 TABLETS
Each tablet contains:
hydrocodone bitartrate 5 mg
acetaminophen 500 mg
Usual adult dosage: See package insert.
Store at 25 degrees C (77 degrees F); excursions permitted to 15
degrees - 30 degrees C
(59 - 86 degrees F). [See USP Controlled Room Temperature].
Dispense in tight, light-resistant container as defined in the USP.
Protect from light.
Do not accept if inner seal is broken or missing.
Manufactured by: Amneal Pharmaceticals of NY
Hauppauge, NY 11788
Distributed by: Amneal Pharmaceuticals
Glasgow, KY 42141
Hydrocodone bitartrate and acetaminophen is supplied in tablet form
for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and
occurs as fine, white crystals or as a
crystalline powder. It is affected by light.
The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one
tartrate (1:1) hydrate (2:5). It
has the following structural formula:
Acetaminophen, 4’-Hyroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-
opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula:
Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral
administration
are available in a variety of strengths as described in the following
table.
Strength Hydrocodone Bitartrate Acetaminophen
2.5 mg/500mg 2.5mg 500mg
5mg/500mg 5mg 500mg
7.5mg/325mg 7.5mg 325mg
7.5mg/500mg 7.5mg 500mg
7.5mg/650mg 7.5mg 650mg
7.5mg/750mg 7.5mg 750mg
10mg/325mg 10mg 325mg
10mg/500mg 10mg 500mg
10mg/650mg 10mg 650mg
10mg/660mg 10mg 660mg
10mg/750mg 10mg 750mg
In addition,