Hydrocodone Bitartrate and Acetaminophen 325 mg; 10 mg Tablet, 10-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.2311 | $2.31 / 10 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 42806-0113-01 | Epic | 100 tablets | $0.135 | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 00406-0125-01 | SpecGx | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 10702-0191-01 | KVK-Tech, | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 13107-0021-01 | Aurolife | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 27808-0037-01 | Cranbury | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 31722-0997-01 | Camber | 100 tablets | $0.152 | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 42858-0203-01 | Rhodes | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 50268-0402-15 | AvPAK | 50 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 53746-0110-01 | Amneal | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 60687-0418-01 | American | 100 tablets | $0.152 | AA | Availability likely | — |
| hydrocodone bitartrate and acetaminophen 10 mg/1; 325 mg 64380-0442-01 | Strides | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 64850-0633-01 | Elite | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71930-0021-12 | Eywa | 100 tablets | $0.152 | AA | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 43386-0358-01 | Lupin | 100 tablets | $0.153 | — | Availability likely | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 00245-0412-01 | Upsher-Smith | 100 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 55700-0991-30 | Quality | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60429-0592-01 | Golden | 100 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 60760-0871-30 | ST. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mg 60760-0872-30 | St. | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0120-20 | Proficient | 20 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63187-0778-12 | Proficient | 12 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 325 mg/1; 10 mgthis 63304-0497-69 | Sun | 10 tablets | — | — | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-1938-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2298-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2299-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2300-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2470-01 | Bryant | 500 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-2471-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 63629-8886-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 66267-0319-30 | NuCare | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 68071-4941-06 | NuCare | 6 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 70010-0674-01 | Granules | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71205-0660-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1271-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1339-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1418-00 | Bryant | 120 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-1444-01 | Bryant | 21 tablets | — | AA | Discontinued | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2105-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2118-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-2740-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9602-01 | Bryant | 21 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 71335-9735-00 | Bryant | 120 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1281-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-1991-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72162-2271-01 | Bryant | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 325 mg/1; 10 mg 72189-0348-30 | DirectRx | 30 tablets | — | AA | FDA listed | — |
| Norco 10 mg/1; 325 mg 72189-0399-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone/APAP 10 mg/1; 325 mg 72189-0650-30 | Direct_Rx | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0112-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 72865-0204-01 | XLCare | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0215-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 76420-0877-00 | Asclemed | 1000 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate And Acetaminophen 10 mg/1; 325 mg 82804-0003-30 | Proficient | 30 tablets | — | AA | FDA listed | — |
| Hydrocodone Bitartrate and Acetaminophen 10 mg/1; 325 mg 87063-0051-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63304-0497-01 | 100 TABLET in 1 BOTTLE (63304-497-01) | 2018-07-31 | Active |
| 63304-0497-03 | 10 TABLET in 1 BOTTLE (63304-497-03) | 2018-07-31 | Active |
| 63304-0497-05 | 500 TABLET in 1 BOTTLE (63304-497-05) | 2018-07-31 | Active |
| 63304-0497-10 | 1000 TABLET in 1 BOTTLE (63304-497-10) | 2018-07-31 | Active |
| 63304-0497-69 You're viewing this | 10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11) | 2018-07-31 | Active |
Pack size FAQ
What quantity is in NDC 63304-0497-69?
What is the difference between NDC 63304-0497-69 and NDC 63304-0497-03?
What NDC number is used to bill for this package of Hydrocodone Bitartrate and Acetaminophen 325 mg; 10 mg Tablet?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 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, USP, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings] . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP.
Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Tablets, USP or following a dose increase [see WARNINGS]. Accidental Ingestion Accidental ingestion of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Tablets, USP [see WARNINGS]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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 WARNINGS]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP with all Cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone 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 plasma concentrations. Monitor patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets, USP and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions]. Hepatotoxicity 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 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS, OVERDOSAGE]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedat…
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): • have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ]. 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 WARNINGS ]. Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Tablets, USP and adjust the dosage accordingly [see WARNINGS ].
Initial Dosage Initiating Treatment with Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets . Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets 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. Conversion from Hydrocodone Bitartrate and Acetaminophen Tablets to Extended-Release Hydrocodone The relative bioavailability of hydrocodone from Hydrocodone Bitartrate and Acetaminophen Tablets compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression.
Titration and Maintenance of Therapy Individually titrate Hydrocodone Bitartrate and Acetaminophen Tablets, USP to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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 WARNINGS ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
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, USP 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.
Discontinuation of Hydrocodone Bitartrate and Acetaminophen Tablets, USP When a patient who has been taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP regularly and may be physically dependent no longer requires therapy with Hydrocodone Bitartrate and Acetaminophen Tablets, USP, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
Do not abruptly discontinue Hydrocodone Bitartrate and Acetaminophen Tablets, USP in a physically-dependent patient [see WARNINGS, DRUG ABUSE AND DEPENDENCE ].
⛔ Contraindications ▾
CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablets, USP are contraindicated in patients with: • Significant respiratory depression [see WARNINGS ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] • Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS, ADVERSE REACTIONS]
⚠️ Warnings ▾
WARNINGS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a Schedule II controlled substance. As an opioid, Hydrocodone Bitartrate and Acetaminophen Tablets exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. 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, but use in such patients necessitates intensive counseling about the risks and proper use of hydrocodone bitartrate and acetaminophen 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.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program thatincludes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. • Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed.
The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG . • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 800-503-0784, or log on to www.opioidanalgesicrems.com .
The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint . Life-Threatening Respiratory Depression 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…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting.
Other adverse reactions include: Central Nervous System - Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System- Constipation. Genitourinary System- Ureteral spasm, spasm of vesical sphincters, and urinary retention.
Special Senses- Cases of Hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological- Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological - Thrombocytopenia, agranulocytosis. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. • Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. • Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY ].
DRUG ABUSE AND DEPENDENCE Controlled Substance Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a substance with a high potential for abuse similar to other opioids including. Hydrocodone Bitartrate and Acetaminophen Tablets, USP can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ].
All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug seeking” behavior is very common in persons with substance use disorders.
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 healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, like other opioids, can be diverted for non-medical use into illicit c…
🔄 Drug Interactions ▾
Drug Interactions Inhibitors of CYP3A4 and CYP2D6 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 from 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 both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Hydrocodone Bitartrate and Acetaminophen Tablets is achieved [see WARNINGS ] .
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Acetaminophen Tablets. If concomitant use is necessary, consider dosage reduction of Hydrocodone Bitartrate and Acetaminophen Tablets until stable drug effects are achieved. Follow patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved . Follow for signs or symptoms of opioid withdrawal. Inducers of CYP3A4 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 [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [see WARNINGS ] .
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see CLINICAL PHARMACOLOGY ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Tablets dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION ] . Follow the patient for signs and symptoms of opioid withdrawal.
If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Tablets dosage reduction and follow for signs of respiratory depression. Benzodiazepines and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see WARNINGS ].
Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; Information for Patients ].
If concomitant use is warranted, carefully follow the patient, particularly during t…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
🤰 Pregnancy ▾
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 Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see WARNINGS ].
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of Hydrocodone Bitartrate and Acetaminophen Tablets in the pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to Hydrocodone Bitartrate and Acetaminophen Tablets. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration.
Titrate the dosage of Hydrocodone Bitartrate and Acetaminophen Tablets slowly in geriatric patients and follow closely for signs of central nervous system and respiratory depression [see WARNINGS ]. Hydrocodone and acetaminophen are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Hepatic Impairment Patients with hepatic impairment may have higher plasma hydrocodone concentrations than those with normal function. Use a low initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets in patients with hepatic impairment and follow closely for adverse events such as respiratory depression and sedation. Renal Impairment Patients with renal impairment may have higher plasma hydrocodone concentrations than those with normal function.
Use a low initial dose Hydrocodone Bitartrate and Acetaminophen Tablets in patients with renal impairment and follow closely for adverse events such as respiratory depression and sedation.
🆘 Overdosage ▾
OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Clinical Presentation Acute overdosage with Hydrocodone Bitartrate and Acetaminophen Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. 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 of Overdose Hydrocodone In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated.
Cardiac arrest or arrhythmias will require advanced life-support techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Tablets overdose, administer an opioid antagonist.
Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Hydrocodone Bitartrate and Acetaminophen Tablets overdose. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in Hydrocodone Bitartrate and Acetaminophen Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product's prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
Acetaminophen 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions. Pharmacodynamics Effects on the Central Nervous System The principal therapeutic action of hydrocodone is analgesia. Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers.
The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Hydrocodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings).
Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Effects on the Gastrointestinal Tract and Other Smooth Muscle Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.
Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.
Effects on the Cardiovascular System Hydrocodone produces peripheral vasodilation which may result in orthostatic hypotension or syncope. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension. Effects on the Endocrine System Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see ADVERSE REACTIONS ].
They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon. Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. 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 [see ADVERSE REACTIONS ].
Effects on the Immune System Opioids have been shown to have a variety of effects on components of the immune system. The clinical significance of these findings is unknown. Overall, the effects of opioids appear to be modestly immunosuppressive.
Concentration–Efficacy Relationships The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. The minimum effective analgesic concentration of hydrocodone for any individual patient may increa…
🧬 Mechanism of Action ▾
Mechanism of Action Hydrocodone is full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone.
Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are available as white to off-white round, uncoated tablets, debossed with “RX” above the bisect and “497” below the bisect on one side and plain on the other side. They are supplied as: NDC 63304-497-03 Bottles of 10 NDC 63304-497-01 Bottles of 100 NDC 63304-497-05 Bottles of 500 NDC 63304-497-10 Bottles of 1000 NDC 63304-497-69 Unit-dose pack of 10 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA July 2018 FDA-14
📋 Description ▾
DESCRIPTION Hydrocodone Bitartrate, USP and Acetaminophen, USP is available in tablet form for oral administration. Hydrocodone bitartrate, USP is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light.
It is soluble in water, slightly soluble in alcohol, insoluble in ether and in chloroform. 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: C 18 H 21 NO 3 • C 4 H 6 O 6 • 2 ½ H 2 O M.W.
494.50 Acetaminophen, USP, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C8H9NO2 M.W. 151.16 Hydrocodone Bitartrate and Acetaminophen Tablets, USP for oral administration are available as follows: Strength Hydrocodone Bitartrate, USP Acetaminophen, USP 10 mg/325 mg 10 mg 325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.
Meets USP Dissolution Test 1. structure1 structure2
💬 Information for Patients ▾
Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Addiction, Abuse, and Misuse Inform patients that the use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share Hydrocodone Bitartrate and Acetaminophen Tablets with others and to take steps to protect Hydrocodone Bitartrate and Acetaminophen Tablets from theft or misuse.
Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Hydrocodone Bitartrate and Acetaminophen Tablets or when the dosage is increased, and that it can occur even at recommended dosages [see WARNINGS ]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ].
Instruct patients to take steps to store Hydrocodone Bitartrate and Acetaminophen Tablets securely and to dispose of unused Hydrocodone Bitartrate and Acetaminophen Tablets by flushing down the toilet. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Hydrocodone Bitartrate and Acetaminophen Tablets, USP are used with benzodiazepines and other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS, PRECAUTIONS; Drug Interactions] .
Serotonin Syndrome Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets, USP could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see PRECAUTIONS; Drug Interactions ].
Monoamine Oxidase Inhibitor (MAOI) Interaction Inform patients to avoid taking Hydrocodone and Acetaminophen Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Hydrocodone and Acetaminophen Tablets [see PRECAUTIONS; Drug Interactions ] . Adrenal Insufficiency Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets, USP could cause adrenal insufficiency, a potentially life-threatening condition.
Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS ]. Important Administration Instructions Instruct patients how to properly take Hydrocodone Bitartrate and Acetaminophen Tablets [see DOSAGE AND ADMINISTRATION, WARNINGS] .
Maximum Daily Dose of Acetaminophen Inform patients not to take more than 4000 milligrams of acetaminophen per day. Advise patients to call their prescriber if they take more than the recommended dose. Hypotension Inform patients that Hydrocodone Bitartrate and Acetaminophen Tablets may cause orthostatic hypotension and syncope.
Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS ]. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Acetaminophen Tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS, ADVERSE REACTIONS ].
Pregnancy Neonatal Opi…
💬 Medication Guide ▾
Medication Guide Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen) Tablets, USP 10 mg/325 mg, CII Hydrocodone Bitartrate and Acetaminophen Tablets, USP are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, 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. Important information about Hydrocodone Bitartrate and Acetaminophen Tablets, USP: • Get emergency help right away if you take too much Hydrocodone Bitartrate and Acetaminophen Tablets, USP (overdose). When you first start taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 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, USP 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, USP.
They could die from taking it. Store Hydrocodone Bitartrate and Acetaminophen Tablets, USP away from children and in a safe place to prevent stealing or abuse. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets, USP is against the law.
Do not take Hydrocodone Bitartrate and Acetaminophen Tablets, USP if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • known hypersensitivity to hydrocodone or acetaminophen, or any ingredient in hydrocodone and acetaminophen tablets. Before taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP, tell your healthcare provider if you have a history of: Tell your healthcare provider if you are: • 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. • pregnant or planning to become pregnant .
Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets, USP during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. • breast feeding. Hydrocodone bitartrate and acetaminophen passes into breast milk and may harm your baby. • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP with certain other medicines can cause serious side effects that could lead to death.
When taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP: • Do not change your dose. Take Hydrocodone Bitartrate and Acetaminophen Tablets, USP exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. • Take your prescribed dose every four to six hours as needed for pain. • 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, USP regularly, do not stop taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP without talking to your healthcare provider. • After you stop taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP the unused tablets should be disposed of by flushing down the toilet. While taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP DO NOT: • Drive or operate heavy ma…