HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EPM Packaging Inc

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

Product summary:

Hydrocodone Bitartrate and Acetaminophen Tablets , USP 5 mg/325 mg are supplied as white with orange specks, capsule-shaped, scored tablets, debossed “3604” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 30: NDC 0603-3890-16 Bottles of 60: NDC 0603-3890-20 Bottles of 90: NDC 0603-3890-02 Bottles of 100: NDC 0603-3890-21 Bottles of 120: NDC 0603-3890-22 Bottles of 180: NDC 0603-3890-04 Bottles of 500: NDC 0603-3890-28 Bottles of 1000: NDC 0603-3890-32 Hydrocodone Bitartrate and Acetaminophen Tablets , USP 7.5 mg/325 mg are supplied as light orange, oval-shaped, scored tablets, debossed “3605” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 90: NDC 0603-3891-02 Bottles of 100: NDC 0603-3891-21 Bottles of 120: NDC 0603-3891-22 Bottles of 120: NDC 0603-3891-22 Bottles of 500: NDC 0603-3891-28 Bottles of 1000: NDC 0603-3891-32 Hydrocodone Bitartrate and Acetaminophen Tablets , USP 10 mg/325 mg are supplied as light yellow, modified capsule-shaped, scored tablets, debossed “3601” on one side and debossed “V” on the reverse side; and supplied as follows: Bottles of 60: NDC 0603-3887-20 Bottles of 90: NDC 0603-3887-02 Bottles of 100: NDC 0603-3887-21 Bottles of 120: NDC 0603-3887-22 Bottles of 150: NDC 0603-3887-26 Bottles of 180: NDC 0603-3887-04 Bottles of 240: NDC 0603-3887-12 Bottles of 500: NDC 0603-3887-28 Bottles of 1000: NDC 0603-3887-32 Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. A Schedule CII Narcotic. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8180185 Rev 8/14

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
EPM PACKAGING INC
----------
Hepatotoxicity:
Acetaminophen has been as s ociated with cas es of acute liver
failure, at times res ulting in
liver trans plant and death. Mos t of the cas es of liver injury are
as s ociated with the us e of
acetaminophen at dos es that exceed 4000 milligrams per day, and often
involve more than
one acetaminophen-containing product.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
CII
Rx only
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'-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a
nonopiate,
non-salicylate analgesic and antipyretic. It has the following
structural formula:
Hydrocodone Bitartrate and Acetaminophen Tablets , USP 5 mg/325 mg
Each tablet contains:
Hydrocodone Bitartrate ................. 5 mg
Acetaminophen ............................. 325 mg
In addition, each tablet contains the following inactive ingredients:
croscarmellose sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized starch, sodium
lauryl sulfate, stearic acid and sugar spheres which are composed of
starch derived from corn, FD&C
Red #40, FD&C Yellow #6, and sucrose. Meets USP Dissolution Test 2.
Hydrocodone Bitartrate and Acetaminophen Tablets , USP 7.5 mg/325 mg
Each tablet contains:
Hydrocodone Bitartrate ............. 7.5 mg
Acetaminophen ......................... 325 mg
In addition, each tablet contains the following inactive ingredients:
croscarmellose sodium, FD&C Red
#40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate,
magnesium stearate,
microcrystalline cel