Generic Vicodin 5-500 mg

Vicodin 5-500 was the original Vicodin tablet: a prescription combination of 5 mg hydrocodone bitartrate, an opioid pain reliever, and 500 mg acetaminophen, a non-opioid pain reliever and fever reducer. No US pharmacy can dispense it today, because the product has been off the American market for years. Abbott stopped making the 500 mg acetaminophen formula in April 2012, and by 2014 no maker was still marketing any prescription combination that packed over 325 mg of acetaminophen into a single tablet. This page references the retired product: what the tablet contained, what its label said, why it was withdrawn, and what to do with any tablets you still have at home.

Tablet Composition and Description

Each Vicodin 5/500 tablet held two active ingredients in a fixed ratio. The fixed ratio meant the dose of one ingredient could not be changed without changing the other.

Component	Amount per tablet	Purpose
Hydrocodone bitartrate	5 mg	Opioid analgesic; reduces how strongly pain is felt
Acetaminophen	500 mg	Non-opioid analgesic and fever reducer
Inactive ingredients	Listed on the original package insert	Bind and shape the tablet; no pain-relieving effect

The Vicodin 5 500 pill imprint was a white, capsule-shaped (oval) tablet debossed with the word “VICODIN”, which pill identification references list as a discontinued Abbott product. Generic hydrocodone acetaminophen 5-500 tablets from other makers carried different imprints, and color and shape differ between manufacturers, as explained in this guide to why generic pills look different from one another. An imprint match alone does not prove what a tablet contains.

Hydrocodone is light-sensitive. Older hydrocodone combination labels directed storage at room temperature, 20 to 25 °C (68 to 77 °F), in a tight, light-resistant container. Any Vicodin 5-500 tablets kept in a bathroom cabinet or a clear pill organizer for years have been exposed to heat, moisture and light well beyond what the label allowed.

How the Two Ingredients Work Together

Hydrocodone: Opioid Receptor Action

Hydrocodone attaches to mu-opioid receptors found along the central nervous system, from the brain down through the spinal cord. These receptors control how pain signals are processed. When hydrocodone attaches, the brain registers less pain, and drowsiness and slowed breathing can follow. A plain-language overview of this system is in understanding opioid receptors. Label data put the time to highest blood concentration at roughly 1.3 hours after swallowing a dose, with a half-life near 3.8 hours. Half-life means the time the body takes to clear half of the drug.

Acetaminophen: Central Pain and Fever Action

Acetaminophen works mainly in the central nervous system to reduce pain and lower fever. It does not act on opioid receptors and has little effect on inflammation. Its half-life is 1.25 to 3 hours, and this can lengthen with liver damage or after an overdose. The liver processes almost all of it, which is why total daily amount matters so much.

Combinations were used because the two drugs relieve pain through different pathways, so together they could give more relief than the same small opioid dose alone.

What the Original Vicodin 5-500 Label Directed

The older hydrocodone/acetaminophen label for this strength (Qualitest, revised February 2012) set out these directions. They are historical facts, not instructions to follow today. Any current dose is set by the prescriber.

• Usual dose: one tablet or two, repeated no sooner than every 4 hours and up to every 6 hours, only when pain required it.
• Maximum: 8 tablets in 24 hours.
• At 8 tablets, the daily intake was 40 mg of hydrocodone and exactly 4,000 mg of acetaminophen.
• That 4,000 mg figure is the full daily acetaminophen ceiling for adults, reached by one product alone.
• Any extra acetaminophen from another medicine on the same day pushed the total past that ceiling.

This leaves no margin. A patient taking the label maximum of hydrocodone 5/500 had no room for a cold remedy or headache tablet that also contained acetaminophen. For how current hydrocodone products are dosed in general, see the hydrocodone dosage guide for adults.

Why the 500 mg Acetaminophen Formula Was Retired

The main reason was liver injury. Acetaminophen has been tied to sudden, severe liver failure, and some of those cases ended in a liver transplant or in death. Current labels note that most cases occur above 4,000 mg a day and often involve more than one acetaminophen-containing product. A tablet with 500 mg made it easy to cross that line without noticing.

Hidden acetaminophen was a key part of the problem. Many over-the-counter products contain it, sometimes listed only as “APAP” or “acetaminophen” in small print:

• Multi-symptom cold and flu products
• Sinus and allergy combination tablets
• Nighttime “PM” pain relievers and sleep aids
• Headache and migraine formulas
• Menstrual pain relievers
• Cough syrups and liquid cold medicines

Several patterns made the 500 mg strength especially risky. Pain that was not fully controlled could lead a patient to take an extra tablet. A short illness could add a cold remedy on top. People who drank alcohol regularly, or who had existing liver disease, had less tolerance for acetaminophen. Early liver injury may cause few symptoms, so the damage was sometimes found late. Lowering the acetaminophen per tablet left more room between a normal day of use and a harmful total.

Doubling up this way is one of the common medication mistakes patients make. MedlinePlus lists the signs and limits for acetaminophen use and overdose.

The regulatory steps came in stages. In 2011, FDA requested that makers of prescription combination products cap acetaminophen at 325 mg in each tablet or capsule. In April 2012, Abbott discontinued the 500 mg acetaminophen Vicodin formula and replaced it with versions containing less acetaminophen per tablet. By March 26, 2014, FDA could report that every maker of prescription combinations above 325 mg acetaminophen had stopped marketing them. A Federal Register notice dated March 27, 2014 withdrew approval of 108 abbreviated new drug applications at the manufacturers’ request, and a second notice targeted six manufacturers.

FDA did not ban hydrocodone or acetaminophen. The action targeted the amount of acetaminophen in each prescription tablet. Hydrocodone combinations with a lower acetaminophen content stayed on the market and are still prescribed.

Is Vicodin 5-500 Still Available?

Short answers to the question “is Vicodin 5/500 discontinued?”:

• ✗ Made in the US: No. The brand formula ended in 2012, and generic 500 mg combinations ended by 2014.
• ✗ Stocked by pharmacies: No. US pharmacies cannot dispense it.
• ✗ Old supply can be used: No. Leftover tablets are years past any useful date, and taking them without a current prescriber’s direction is unsafe. They should not be shared.
• ✓ Hydrocodone–acetaminophen still prescribed: Yes. Lower-acetaminophen hydrocodone combinations capped at 325 mg a tablet remain in use; they sit in Schedule II and are dispensed only with a valid prescription.

Current labeling reserves these products for pain serious enough to call for an opioid after other options have fallen short, and it directs prescribers to use as little as works for as few days as possible. The current generic label on DailyMed opens with boxed warnings on addiction and misuse, breathing problems, accidental ingestion, benzodiazepine use, neonatal withdrawal, CYP3A4 interactions and liver damage. Background on the drug itself is in this overview of hydrocodone’s uses and effects.

From Schedule III to Schedule II

When Vicodin 5-500 was on the market, hydrocodone combination products were Schedule III. The DEA moved all of them to Schedule II effective October 6, 2014, under a final rule published August 22, 2014. Any discussion of Vicodin schedule II status applies to the hydrocodone products that remain available, not to the retired tablet.

Rule	Before Oct 6, 2014 (Schedule III)	After Oct 6, 2014 (Schedule II)
Refills	Prescriber could authorize refills	No refills; a new prescription each time
How the prescription reaches the pharmacy	Phone-in and fax were commonly accepted	Written or electronic prescription; phone-in only in narrow emergency cases
Quantity	Supply could be extended through refills	Limited to the amount written on that prescription
PDMP check	Practices varied by state	Prescribers and pharmacists routinely review the state database; rules vary by state

The change was made because hydrocodone combination products were among the most widely prescribed opioids, and Schedule III status allowed easier repeat dispensing. Schedule II places them under the same controls as other strong opioids. For patients, this means planning ahead: each fill needs its own prescription, and a pharmacy cannot add tablets beyond what the prescriber wrote.

A PDMP is a state database of controlled-substance prescriptions; see how the prescription drug monitoring program works. Many Schedule II prescriptions are now sent electronically, as described in this overview of electronic prescribing for controlled substances (EPCS).

Side Effects Reported With Hydrocodone and Acetaminophen

The effects below come from current hydrocodone–acetaminophen labeling and MedlinePlus. They describe the drug combination in general, which is the same pair of ingredients found in hydrocodone 5/500.

Common Effects

• Light-headedness and dizziness
• Sedation and drowsiness
• Nausea and vomiting
• Constipation, which often lasts as long as the opioid is taken (see why opioids cause constipation)
• Mental clouding and mood changes

Dizziness and light-headedness are often worse when standing up quickly, and they add to the risk of falls, especially in older adults. Drowsiness and slower reactions mean driving or running machinery should wait until the individual response to the medicine is clear. Nausea is usually most noticeable with the first doses. Constipation does not tend to fade with time the way nausea can, so prescribers often plan for it from the start.

Call the Prescriber

• Trouble passing urine (urinary retention)
• Itching or a mild rash
• Any hearing change or hearing loss
• Nausea, loss of appetite, tiredness or dizziness that does not ease, which can signal adrenal insufficiency (low adrenal hormone output)
• Low sex drive or other signs of low hormone levels with longer use

Emergency Signs

• Breathing that becomes slow or shallow, or stops
• Heavy drowsiness, or no response when spoken to or shaken
• Narrowed or widened pupils, slow heartbeat, or cold, clammy or blue skin
• Agitation, fever, sweating, fast heartbeat or muscle stiffness, which may be serotonin syndrome
• Swelling of the face or throat, or trouble breathing from an allergic reaction (anaphylaxis)
• Blistering, peeling or a spreading rash; serious skin reactions such as Stevens-Johnson syndrome are rare, and the drug is stopped at the first rash
• Possible liver injury: yellowing of the eyes or skin, urine the color of tea, or pain under the right ribs

Call 911 if someone collapses, has a seizure, has trouble breathing or cannot be woken. The overdose-reversal medicines naloxone and nalmefene work quickly, yet hydrocodone may outlast them, so someone who responds still needs close observation; FDA explains this in its page on naloxone and nalmefene. For other questions, Poison Control is at 1-800-222-1222. More guidance is in when to go to the ER while taking an opioid.

Who Should Not Take Hydrocodone–Acetaminophen

Current labeling lists these contraindications, meaning situations where the combination should not be used:

• Significant respiratory depression (dangerously slowed breathing)
• Acute or severe bronchial asthma in a setting without monitoring or resuscitation equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus (a bowel that has stopped moving)
• Hypersensitivity (allergy) to hydrocodone, acetaminophen or any tablet ingredient

Extra caution applies to older adults, people with liver or kidney disease, lung disease, or a history of substance use. Some of these patients are started on reduced amounts, as explained in why some patients need lower doses.

Interactions

Other CNS Depressants

Benzodiazepines (such as anti-anxiety medicines), alcohol, sleep medicines, muscle relaxants and other opioids all slow the central nervous system. Taken alongside hydrocodone, they may deepen sedation and suppress breathing to the point of coma or a fatal outcome. This risk is one of the boxed warnings on current labels.

CYP3A4 Inhibitors and Inducers

Hydrocodone is cleared largely through CYP3A4, an enzyme in the liver. Inhibitors such as erythromycin, ketoconazole and ritonavir can raise hydrocodone levels and lead to potentially fatal breathing problems. Stopping an inducer, a drug that speeds up the enzyme, can also raise hydrocodone levels.

Serotonergic Drugs

Antidepressants and other medicines that raise serotonin can, together with an opioid, trigger serotonin syndrome. Signs include agitation, fever, shaking and a fast heartbeat. Symptoms usually appear within hours of starting or raising the dose of one of the drugs, and they need prompt medical care.

Other Acetaminophen

Any other product with acetaminophen adds to the daily total. With the old Vicodin 5-500 tablet, the label maximum already reached 4,000 mg, so any extra acetaminophen went over the limit. MedlinePlus covers this and other combinations on its hydrocodone combination products page.

A full list of current medicines, including over-the-counter products, vitamins and herbal supplements, helps a prescriber and pharmacist check for these interactions before any opioid is started.

Pregnancy and Breastfeeding

When a pregnant person uses an opioid for a long stretch, the baby may be born with neonatal opioid withdrawal syndrome (NOWS), withdrawal symptoms that can become serious if not treated. Opioids can also affect a breastfed infant, so nursing parents should tell a clinician right away if the infant seems unusually hard to wake or breathes poorly. Anyone pregnant, planning pregnancy or breastfeeding needs a prescriber’s review before any opioid. Related reading: opioid risks during pregnancy.

Old Vicodin 5-500 Tablets at Home

Leftover tablets are a risk to children, pets and visitors. Here is how to dispose of old Vicodin:

1. Do not take the tablets, even for a new episode of pain. Talk to a prescriber instead.
2. Do not give them to anyone else. Sharing a controlled drug is unsafe and illegal.
3. Keep them locked and out of sight until disposal.
4. Use a drug take-back site or a mail-back envelope first. Many pharmacies and police stations have collection kiosks, and national take-back days are held each year.
5. If take-back or mail-back is not readily available, flush the tablets. Any drug containing hydrocodone is on FDA’s flush list.
6. Scratch out personal details on the bottle label, then place the empty container in household trash.

A tablet that cannot be identified should never be taken. If a child or pet may have swallowed even one tablet, contact the Poison Help line (1-800-222-1222) at once, or 911 if there are breathing problems or the child cannot be woken. Accidental ingestion of hydrocodone can be fatal, especially in children.