
Prescription Drug Name:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII, 7.5 mg/325 mg and 10 mg/325 mg, Rx only
ID:
638c8369-e57e-cbb0-e053-2991aa0a0be2
Code:
34391-3
BOXED WARNING SECTION
id: 638c8369-e55f-cbb0-e053-2991aa0a0be2
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
Hydrocodone bitartrate and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydrocodone bitartrate and acetaminophen tablets and monitor all patients regularly for the development of these behaviors or conditions [see
Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see
Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen tablets [see
Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see
The concomitant use of hydrocodone bitartrate and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone bitartrate and acetaminophen tablets plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used
cytochrome P450 3A4 inducer may result in an increase in hydrocodone bitartrate and acetaminophen tablets plasma concentrations. Monitor patients receiving hydrocodone bitartrate and acetaminophen tablets and any CYP3A4 inhibitor or inducer [see
Inhibitor
The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone bitartrate and acetaminophen tablets resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and acetaminophen tablets is achieved [see
The concomitant use of hydrocodone bitartrate and acetaminophen tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone bitartrate and acetaminophen tablets [see
Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression [see
Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen [see
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see
• Reserve concomitant prescribing of hydrocodone bitartrate and acetaminophen tablets and
benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.
DESCRIPTION
id: 638c8369-e560-cbb0-e053-2991aa0a0be2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each hydrocodone bitartrate and acetaminophen tablet, USP 10 mg/325 mg contains:
Hydrocodone bitartrate, USP ……………………. 10 mg
Acetaminophen, USP ……………………………… 325 mg
CLINICAL PHARMACOLOGY
id: 638c8369-e561-cbb0-e053-2991aa0a0be2
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
id: 638c8369-e562-cbb0-e053-2991aa0a0be2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia
CONTRAINDICATIONS
id: 638c8369-e563-cbb0-e053-2991aa0a0be2
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
• Significant respiratory depression [see
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see
• Hydrocodone bitartrate and acetaminophen tablets should not be administered to patients with known hypersensitivity to hydrocodone, acetaminophen, or any other component of this product.
• Hydrocodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Hydrocodone is contraindicated in the setting of suspected or known paralytic ileus.
WARNINGS
id: 638c8369-e564-cbb0-e053-2991aa0a0be2
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone bitartrate, a Schedule II controlled substance. As an opioid, hydrocodone and acetaminophen tablets exposes users to the risks of addiction, abuse, and misuse [see
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and monitor all patients receiving hydrocodone bitartrate and acetaminophen tablets for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as hydrocodone bitartrate and acetaminophen tablets, but use in such patients necessitates intensive counseling about the risks and proper use of hydrocodone bitartrate and acetaminophen tablets along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PRECAUTIONS; Information for Patients]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with and following dosage increases of hydrocodone bitartrate and acetaminophen tablets.
To reduce the risk of respiratory depression, proper dosing and titration of hydrocodone bitartrate and acetaminophen tablets are essential [see
Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone bitartrate.
In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized [see
Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see
Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced. The concurrent use of anticholinergics with opioids may produce paralytic ileus.
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as hydrocodone. These agonist/antagonist analgesics may reduce the analgesic effect of hydrocodone or may precipitate withdrawal symptoms.
Depending on the sensitivity/specificity and the test methodology, the individual components of hydrocodone bitartrate and acetaminophen tablets may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Acetaminophen may interfere with home blood glucose measurement systems; decreases of > 20% in mean glucose values may be noted. This effect appears to be drug, concentration and system dependent.
Concomitant use of hydrocodone bitartrate and acetaminophen tablets with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone bitartrate and acetaminophen tablets and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see
Concomitant use of hydrocodone bitartrate and acetaminophen tablets with CYP3A4 inducers or discontinuation of an CYP3A4 inhibitor could decrease hydrocodone bitartrate and acetaminophen tablets plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone and acetaminophen tablets. When using hydrocodone bitartrate and acetaminophen tablets with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal [see
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of hydrocodone bitartrate and acetaminophen tablets with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
Advise both patients and caregivers about the risks of respiratory depression and sedation when hydrocodone bitartrate and acetaminophen tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see
The use of hydrocodone bitartrate and acetaminophen tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Monitor such patients closely, particularly when initiating and titrating hydrocodone bitartrate and acetaminophen tablets is given concomitantly with other drugs that depress respiration [see
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than 1 month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Animal reproductive studies have not been conducted with hydrocodone and acetaminophen. It is also not known whether hydrocodone and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Hydrocodone bitartrate and acetaminophen tablets should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Hydrocodone and acetaminophen tablets are not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.
Ordinarily, nursing should not be undertaken while a patient is receiving hydrocodone bitartrate and acetaminophen tablets because of the possibility of sedation and/or respiratory depression in the infant. Hydrocodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking a hydrocodone/acetaminophen product. Acetaminophen is also excreted in breast milk in low concentrations.
Safety and effectiveness in pediatric patients have not been established.
Special precaution should be given when determining the dosing amount and frequency of hydrocodone bitartrate and acetaminophen tablets for geriatric patients, since clearance of hydrocodone may be slightly reduced in this patient population when compared to younger patients.
In a pharmacokinetic study of hydrocodone in patients with end-stage liver disease, hydrocodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when hydrocodone is used in patients with hepatic impairment.
In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Hydrocodone should be used with caution in patients with renal impairment.
ADVERSE REACTIONS
id: 638c8369-e575-cbb0-e053-2991aa0a0be2
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
• serotonin syndrome
• adrenal insufficiency
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms of hypogonadism, such as impotence, erectile dysfunction, or amenorrhea. The causal role of opioids in the syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in
studies conducted to date. Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation.
OVERDOSAGE
id: 638c8369-e578-cbb0-e053-2991aa0a0be2
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: 638c8369-e57a-cbb0-e053-2991aa0a0be2
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets and adjust the dosage accordingly [see
Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
Patients should be advised that hydrocodone bitartrate and acetaminophen tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
Initiate treatment with hydrocodone bitartrate and acetaminophen tablets in a dosing range of one or two tablets every 4 to 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of hydrocodone bitartrate and acetaminophen tablets. It is safer to underestimate a patient’s 24-hour hydrocodone bitartrate and acetaminophen tablets dosage than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen tablets dosage and manage an adverse reaction due to overdose.
When using hydrocodone bitartrate and acetaminophen tablets with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal [see
If the decision to begin hydrocodone bitartrate and acetaminophen tablets is made, start with a lower dosage of hydrocodone bitartrate and acetaminophen tablets [see
Special precaution should be given when determining the dosing amount and frequency of hydrocodone bitartrate and acetaminophen tablets for geriatric patients [see
Safety and effectiveness in pediatric patients have not been established [see
Dosage Modification in Patients with Chronic Pulmonary Disease are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of hydrocodone bitartrate and acetaminophen tablets [see
Hydrocodone should be used with caution in patients with renal impairment.
Care should be exercised when hydrocodone is used in patients with hepatic impairment.
Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely, particularly when initiating and titrating hydrocodone bitartrate and acetaminophen tablets and when hydrocodone bitartrate and acetaminophen tablets is given concomitantly with other drugs.
Individually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodone bitartrate and acetaminophen tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the hydrocodone bitartrate and acetaminophen tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
When a patient who has been taking hydrocodone bitartrate and acetaminophen tablets regularly and may be physically dependent no longer requires therapy with hydrocodone bitartrate and acetaminophen tablets, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal. Do not stop hydrocodone bitartrate and acetaminophen tablets abruptly [see
HOW SUPPLIED
id: 638c8369-e57b-cbb0-e053-2991aa0a0be2
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
They are available as follows:
Hydrocodone bitartrate and acetaminophen tablets, USP
They are available as follows:
Bottles of 100: NDC 42291-334-01
Pulaski, TN 38478
SPL MEDGUIDE SECTION
id: 638c8369-e57c-cbb0-e053-2991aa0a0be2
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
(hye-droe-KOE-dohne bye-TAR-trate/a-SEET-a-MIN-oh-fen) Tablets, USP – CII
• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage moderate to moderately severe pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Get emergency help right away if you take too much hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking hydrocodone bitartrate and acetaminophen tablets, when your dose is changed, or if you take too much overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking hydrocodone bitartrate and acetaminophen tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your hydrocodone bitartrate and acetaminophen tablets. They could die from taking it. Store hydrocodone bitartrate and acetaminophen tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away hydrocodone bitartrate and acetaminophen tablets is against the law.
• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
•
•
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone bitartrate and acetaminophen tablets with certain other medicines can cause serious side effects that could lead to death.
• Do not change your dose. Take hydrocodone bitartrate and acetaminophen tablets exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 6 hours at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking hydrocodone bitartrate and acetaminophen tablets regularly, do not stop taking hydrocodone bitartrate and acetaminophen tablets without talking to your healthcare provider.
• After you stop taking hydrocodone bitartrate and acetaminophen tablets dispose of unused drug.
• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
This Medication Guide has been approved by U.S. Food and Drug Administration.
Manufactured for:
Pulaski, TN 38478
Mfg Rev. 09-2016-00 AV Rev. 10/16
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 638c8369-e57d-cbb0-e053-2991aa0a0be2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 42291-
7.5 mg/ 325 mg
MULTIPLE STRENGTHS: DO NOT DISPENSE UNLESS STRENGTH IS STATED
100 Tablets
Hydrocodone Bitartrate, USP………7.5 mg
Acetaminophen, USP………325 mg
Protect from light.
o to 25
oC (68
o to 77
oF); excursions permitted to 15
o to 30
oC (59
o to 86
oF) [see USP Controlled Room Temperature].
Pulaski, TN 38478
Mfg. Rev. 09-2016-01 AV 10/16
NDC 42291-
10 mg/ 325 mg
MULTIPLE STRENGTHS: DO NOT DISPENSE UNLESS STRENGTH IS STATED
100 Tablets
Acetaminophen, USP………325 mg
Protect from light.
o to 25
oC (68
o to 77
oF); excursions permitted to 15
o to 30
oC (59
o to 86
oF) [see USP Controlled Room Temperature].
DEA ORDER FORM REQUIRED.
Pulaski, TN 38478
Mfg. Rev. 04-2016-02 AV 10/16