Generic Vicodin 7.5/750 mg

Vicodin 7.5/750, sold as Vicodin ES, was a brand-name tablet that combined 7.5 mg of hydrocodone bitartrate with 750 mg of acetaminophen for pain relief. The product is discontinued in the United States and is no longer made, stocked, or dispensed. This page is a reference record of what the tablet was, what its label said, why it left the market, and how to handle any leftover tablets safely.

Vicodin 7.5/750 Product Record

Field	Detail
Brand name	Vicodin ES
Generic name	Hydrocodone bitartrate and acetaminophen tablets
Strengths per tablet	Hydrocodone bitartrate 7.5 mg; acetaminophen 750 mg
Dosage form	Oral tablet
Imprint	“VICODIN ES” on a white, oval (capsule-shaped) tablet
Original maker	Abbott (the brand later passed to AbbVie)
Controlled status then / now	Schedule III while marketed; any hydrocodone combination product is Schedule II today
US status	Discontinued; not available
Replacement category	Hydrocodone–acetaminophen products with 325 mg or less of acetaminophen per tablet

A prescription was always required for Vicodin ES while it was marketed. Today it cannot be prescribed or dispensed, because no approved product of this strength remains in the US.

What the ES in Vicodin ES Meant

ES stood for “extra strength.” The label carried it because each tablet held a larger amount of both ingredients than a standard tablet of the brand. The extra strength applied to the acetaminophen as well as the opioid, and the 750 mg acetaminophen content is the main reason the product no longer exists.

The name did not signal a different drug. Vicodin ES used the same two ingredients as other hydrocodone 7.5/750 tablets made under generic labels. Only the brand name and the “VICODIN ES” imprint set it apart.

Composition of Hydrocodone Acetaminophen 7.5/750

Each tablet paired an opioid with a non-opioid pain reliever. The two work in different ways, so combining them was meant to relieve pain at a lower opioid dose than the opioid alone would need.

Hydrocodone bitartrate 7.5 mg

• Role: The opioid part of the tablet. It provided most of the pain relief for moderate to severe pain.
• How it acts: Hydrocodone binds to opioid receptors in the brain and spinal cord. This changes how pain signals are felt. The same action slows breathing and causes drowsiness, which is the source of its main risks. A broader overview is in this guide to what hydrocodone is and how it is used.
• Pharmacokinetics: Pharmacokinetics means how the body absorbs, spreads, breaks down, and removes a drug. In label studies of a 10 mg oral dose, hydrocodone reached its peak blood level in about 1.3 hours and its level fell by half roughly every 3.8 hours. The liver breaks it down partly through an enzyme called CYP3A4, which is why some other drugs change hydrocodone levels.

Acetaminophen 750 mg

• Role: The non-opioid part. It added pain relief and reduces fever.
• How it acts: Acetaminophen is thought to work mainly in the central nervous system. It does not slow breathing the way an opioid does. Its main danger is to the liver when the daily total gets too high.
• Pharmacokinetics: Acetaminophen has a half-life of about 1.25 to 3 hours. That time can lengthen after an overdose or in people with liver damage, so the drug stays in the body longer when the liver is already under strain.

At 750 mg, the acetaminophen in one tablet was more than double the 325 mg per-unit limit that later applied to all prescription combination products. That gap is the core of the product’s history.

The fixed ratio also mattered. Because both ingredients sat in one tablet, the acetaminophen dose rose every time the hydrocodone dose rose. A person who needed more opioid effect could not get it from this tablet without also taking more acetaminophen. Lower-acetaminophen products reduce that coupling, which is part of why the 325 mg cap made clinical sense.

Historical Label Directions for Vicodin 7.5/750

The directions below come from an older hydrocodone–acetaminophen label for this strength. They are shown for reference only. They are not current directions, and nobody should use them to take an old tablet.

• Usual adult dose: a single tablet, repeated at intervals of 4 to 6 hours only when pain called for it.
• Vicodin ES maximum dose: no more than 5 tablets in 24 hours.
• The dose was to be set by the prescriber based on pain level and the person’s response.
• Patients were told not to take other products that contain acetaminophen at the same time.
• Alcohol was to be avoided because of added sedation and liver strain.
• Tablets were to be kept away from children and stored away from light, since hydrocodone is light-sensitive.

Five tablets of Vicodin 7.5/750 added up to 37.5 mg of hydrocodone and 3,750 mg of acetaminophen in one day.

The commonly cited daily limit for acetaminophen in adults is 4,000 mg. A full day at the label maximum sat only 250 mg below that line, which is less than one regular-strength over-the-counter tablet. A single extra Vicodin ES tablet, or one dose of a cold remedy, sleep aid, or headache product that also contained acetaminophen, could push the total past 4,000 mg. Many people did not know that those other products contained acetaminophen at all. The question of combining acetaminophen with an opioid tablet is covered in more depth on the page about taking acetaminophen alongside an opioid.

Regulatory Status by Agency

Vicodin ES was discontinued as part of a wider change across all prescription combination products, not because of a problem specific to one brand. Abbott stopped making its higher-acetaminophen Vicodin tablets in April 2012 and moved to lower-acetaminophen formulations. Federal action then closed the category for every maker.

Agency or setting	Action	Effect on Vicodin ES
FDA	In 2011, FDA asked manufacturers to limit prescription combination products to 325 mg of acetaminophen per tablet or capsule. On March 26, 2014, FDA announced that all makers of products above 325 mg had stopped marketing them. A Federal Register notice on March 27, 2014 withdrew approval of 108 generic applications (ANDAs) at the makers’ request.	Any 750 mg acetaminophen combination tablet, including generic hydrocodone 7.5/750, lost its path to the US market.
DEA	A final rule published August 22, 2014 moved all hydrocodone combination products from Schedule III to Schedule II, effective October 6, 2014.	Vicodin ES was a Schedule III drug while sold. Had it remained, it would now be Schedule II.
Pharmacy practice today	Pharmacies do not stock Vicodin ES or any 750 mg acetaminophen combination tablet.	Hydrocodone combinations dispensed today are Schedule II, so refills are not permitted and every dispensing requires a fresh prescription.

The Schedule II rules that now apply to every hydrocodone combination are explained in this guide to Schedule II prescription rules for patients.

Risk Profile of Hydrocodone–Acetaminophen Tablets

The current hydrocodone bitartrate and acetaminophen label on DailyMed carries a boxed warning, the FDA’s strongest label warning. Its topics apply to the whole drug class, and they applied to Vicodin ES as well.

1. Addiction, abuse, and misuse: Addiction may develop even in people who follow their directions exactly, and misuse raises the chance of overdose and death.
2. Life-threatening respiratory depression: Breathing can slow or stop, most often when starting the drug or after a dose increase.
3. Accidental ingestion: A child who swallows even a single tablet may suffer a fatal overdose.
4. Use with benzodiazepines or other CNS depressants: Taking hydrocodone alongside alcohol or other drugs that slow the brain may lead to deep sedation, breathing problems, coma, and death.
5. Neonatal opioid withdrawal syndrome (NOWS): Long-term use during pregnancy can cause withdrawal in the newborn after birth.
6. Opioid Analgesic REMS: Under a federal safety program, those who prescribe opioids and those who receive them are given training and information about the risks.
7. Cytochrome P450 3A4 interaction: Drugs that block the CYP3A4 enzyme, or stopping drugs that speed it up, can raise hydrocodone levels to a dangerous point.
8. Hepatotoxicity: Acetaminophen can cause acute liver failure, sometimes needing a transplant or ending in death, mostly at doses above 4,000 mg a day.

Beyond the boxed warning, the label lists light-headedness, dizziness, sedation, nausea, and vomiting as the reactions reported most often. Others include constipation, mental clouding, mood changes, itching, and trouble passing urine. Rare skin reactions such as Stevens-Johnson syndrome can occur, and a new rash is a reason to stop and seek care. Patient-level detail is in the overview of common side effects of hydrocodone. Drowsiness can be strong enough to affect driving, work, and caring for others. The full list of cautions is collected in hydrocodone warnings to know before use.

Groups Who Needed Extra Caution

Some people faced higher risk from a tablet like Vicodin 7.5/750 because of the opioid, the high acetaminophen load, or both.

Group	Why
People with liver disease	A damaged liver clears acetaminophen more slowly, and 750 mg per tablet left little room before liver injury. Background on liver blood tests is in this page on liver enzymes and opioid pain medicine.
People who drink alcohol regularly	Alcohol adds to opioid sedation and also stresses the liver alongside acetaminophen.
Older adults	They may be more sensitive to sedation and slowed breathing, and falls are more likely.
People with lung or breathing conditions	Conditions such as COPD or sleep apnea raise the risk of dangerous respiratory depression.
Pregnant people	Prolonged opioid use can lead to NOWS in the newborn.
People with a history of substance use disorder	The risk of addiction and misuse is higher.
People with kidney problems	Drug clearance may be slower, which can lead to build-up.
People with adrenal problems or low blood pressure	Opioids can cause adrenal insufficiency and can lower blood pressure further.

Interactions by Drug Class

Both ingredients in Vicodin 7.5/750 interact with other drugs. The table lists the main classes named on hydrocodone–acetaminophen labels.

Class	Examples	Concern
Benzodiazepines	Anti-anxiety and sleep medicines in this class	Deep sedation, slowed or stopped breathing, coma, death
Other CNS depressants	Alcohol, sleep aids, muscle relaxants, other opioids	Added sedation and respiratory depression
CYP3A4 inhibitors	Erythromycin, ketoconazole, ritonavir	Higher hydrocodone levels; possibly fatal respiratory depression
CYP3A4 inducers (when stopped)	Drugs that speed up CYP3A4	Stopping them lets hydrocodone levels rise
Serotonergic drugs	Certain antidepressants and migraine medicines	Serotonin syndrome
Other acetaminophen products	Over-the-counter pain, cold, flu, and sleep products	Total daily acetaminophen above 4,000 mg; liver injury
Anticholinergic drugs	Some bladder and allergy medicines	Urinary retention and severe constipation

The same enzyme and sedation concerns apply across opioid pain medicines, as outlined in this page on opioid drug interactions to know.

Identifying a Vicodin ES Tablet

The Vicodin ES imprint was the word “VICODIN ES” on a white, oval, capsule-shaped tablet. Generic hydrocodone 7.5/750 tablets from other makers carried their own imprints, colors, and shapes, so a white oval tablet without that marking may still have been the same strength. Because the product left the market in 2014 or earlier, any tablet found today is years past any usable date. Hydrocodone also breaks down with light exposure, so the contents may not match the label.

If an old Vicodin ES tablet or bottle turns up at home, these steps apply:

1. Do not take it. It is expired, it holds more acetaminophen than any current product allows, and it was never prescribed for current pain.
2. Do not share it. Giving an opioid to another person is unsafe and illegal. The risks are covered in what happens when someone else takes your prescription.
3. Secure it. Keep it in its original container, out of reach and out of sight of children, teens, visitors, and pets, until it can be disposed of.
4. Dispose of it. Use the options in the next section. A pharmacist can help confirm what the tablet is.

An unlabeled white oval tablet should never be assumed to be Vicodin ES or any other medicine. Pill identification by appearance alone is not reliable, and a counterfeit or unknown tablet can contain other drugs. A pharmacist or Poison Control can give guidance without the tablet being taken.

Disposal Options, Ranked by Preference

The FDA’s guidance on unused medicines ranks disposal methods. For leftover Vicodin ES tablets, the steps are:

1. Drug take-back: Use a permanent collection kiosk, often found in pharmacies or police stations, or a community take-back event held by the DEA.
2. Mail-back: Use a prepaid mail-back envelope, which some pharmacies and programs supply for controlled medicines.
3. Flushing: If take-back and mail-back are not readily available, flush the tablets down the toilet. Any drug containing hydrocodone is on the FDA flush list, because the danger of one tablet reaching the wrong person outweighs the environmental concern.

Children are at special risk. A single hydrocodone tablet can be fatal to a small child, and old bottles in drawers or handbags are easy to reach. Locking medicines away and clearing out expired opioids are the most effective steps. Practical household advice is in this guide on keeping children safe around prescription opioids.

Vicodin ES Questions

Q: Is Vicodin 7.5/750 still made?

A: No. Vicodin ES is discontinued in the US. Abbott stopped making it in April 2012, and by March 2014 FDA reported that no maker was marketing any prescription combination product with more than 325 mg of acetaminophen per tablet. It is not available from any pharmacy.

Q: Can old Vicodin ES tablets be taken?

A: No. Any tablet still around is long expired, may have degraded, and contains an amount of acetaminophen no longer allowed in prescription combinations. Old tablets should be disposed of, not taken or given to anyone. Current pain treatment needs a fresh evaluation by a prescriber.

Q: How long does hydrocodone 7.5/750 stay in the system?

A: Blood levels of hydrocodone drop by half in roughly 3.8 hours, and acetaminophen levels in about 1.25 to 3 hours, but detection windows in drug tests are longer and depend on the test type and the person. Details are in this page on how long hydrocodone stays in your system.

Q: What is the Vicodin ES imprint?

A: The brand tablet was white, oval, and capsule-shaped, marked “VICODIN ES.” Generic hydrocodone acetaminophen 7.5 750 tablets from other makers had different markings.

Q: Why was Vicodin ES discontinued?

A: The main reason was liver safety. Acetaminophen is a leading cause of acute liver failure when daily totals run too high, often because people take more than one acetaminophen product. At 750 mg per tablet, the label maximum of 3,750 mg a day left little margin. FDA asked makers to cap prescription combinations at 325 mg per unit, and the higher-dose products were withdrawn.

Q: What replaced Vicodin 7.5/750?

A: In general terms, hydrocodone–acetaminophen products with 325 mg or less of acetaminophen per tablet took the place of the higher-dose tablets. Prescribers may also choose other opioid or non-opioid treatments; a comparison of two common opioid options is in oxycodone vs Vicodin. The right choice depends on the person and is made by the prescriber.

Q: Is Vicodin ES a Schedule II drug?

A: While it was sold, Vicodin ES was Schedule III. Since October 6, 2014, all hydrocodone combination products are Schedule II, which means a new prescription is needed for each fill and refills are not allowed. Vicodin 7.5/750 left the market before it could be dispensed under that rule.

The details above describe a product that no longer exists and serve as a historical record. Whether a hydrocodone–acetaminophen product or any other treatment fits a person’s pain today is a decision for a licensed prescriber who knows the full medical history. Patient information on current hydrocodone combinations is also available from MedlinePlus.