Hydrocodone bitartrate and acetaminophen tablets, USP are indicated for the relief of moderate to
moderately severe pain.

Dosage should be adjusted according to the severity of the pain and the response of the patient.
However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and
that the incidence of untoward effects is dose related.
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose
should not exceed 6 tablets.

Patients receiving other narcotic analgesics, antihistamines, antipsychotics, anti-anxiety agents, or other
CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen
tablets may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of
one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase
the effect of either the antidepressant or hydrocodone.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Carcinogenes is , Mutagenes is , Impairment of Fertility
No adequate studies have been conducted in animals to determine whether hydrocodone or
acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Pregnancy
Teratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in
pregnant women. Hydrocodone bitartrate and acetaminophen tablets should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to
delivery will be physically dependent. The withdrawal signs include irritability and excessive crying,
tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning,
vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of
maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.
Labor and Delivery
As with all narcotics, administration of this product to the mother shortly before delivery may result in
some degree of respiratory depression in the newborn, especially if higher doses are used.
Nurs ing Mothers
Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing
infants is not known. It is not known whether hydrocodone is excreted in human milk. Because many
drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing
infants from hydrocodone and acetaminophen, a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

DRUG ABUSE AND DEPENDENCE
Mis us e, Abus e, And Divers ion Of Opioids
Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a
Schedule II controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids,
used in analgesia can be abused and are subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental
factors influencing its development and manifestations. It is characterized by behaviors that include one
or more of the following: impaired control over drug use, compulsive use, continued use despite harm,
and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is
common.
“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include
emergency calls or visits near the end of office hours, refusal to undergo appropriate examination,
testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to
provide prior medical records or contact information for other treating physician(s). “Doctor shopping”
to obtain additional prescriptions is common among drug abusers and people suffering from untreated
addiction.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical
dependence usually assumes clinically significant dimensions only after several weeks of continued
opioid use, although a mild degree of physical dependence may develop after a few days of opioid
therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree
of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by
decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.
Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is
characterized by misuse for non-medical purposes, often in combination with other psychoactive
substances. Hydrocodone bitartrate and acetaminophen tablets, like other opioids, may be diverted for
non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal
requests is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and
proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

OVERDOSAGE
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Signs and Symptoms
Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a
decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme
somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and
sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac
arrest and death may occur.
Acetaminophen: In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the
most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may
also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting,
diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be
apparent until 48 to 72 hours post-ingestion.
Treatment
A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal
polydrug overdose, and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures to reduce drug
absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be
employed as indicated. Assisted or controlled ventilation should also be considered.
For hydrocodone overdose, primary attention should be given to the reestablishment of adequate
respiratory exchange through provision of a patent airway and the institution of assisted or controlled
ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory
depression which may result from overdosage or unusual sensitivity to narcotics, including
hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient
should be kept under continued surveillance, and repeated doses of the antagonist should be
administered as needed to maintain adequate respiration. A narcotic antagonist should not be
administered in the absence of clinically significant respiratory or cardiovascular depression.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine
(NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have
occurred within a few hours of presentation. Serum acetaminophen levels should be obtained
immediately if the patient presents 4 hours or more after ingestion to assess potential risk of
hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To
obtain the best possible outcome, NAC should be administered as soon as possible where impending or
evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude
oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing
absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs
early in the course of intoxication.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP - CII
10 mg/325 mg
Rx only

Hydrocodone Bitartrate and Acetaminophen Tablets, USP are 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: 4,5a-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:
Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP contains:
Hydrocodone Bitartrate, USP ......................... 10 mg
Acetaminophen, USP .................................... 325 mg
In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide,
crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and
stearic acid.
Meets USP Dissolution Test 1.

[image: img_2a54db90-a4bf-6801-e054-00144ff8d46c]

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 325 mg are supplied as white to offwhite,
scored, oblong biconvex tablets, debossed “IP 110” on obverse and bisected on the reverse.
Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen.
They are available as follows:
Bottles of 100: NDC 53746-110-01
Bottles of 500: NDC 53746-110-05
Bottles of 1000: NDC 53746-110-10
Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See
USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.
A Schedule CII Narcotic.
DEA Order Form Required.
MFG Addres s
Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788
Rev. 08-2015-01