Acetaminophen, butalbital, caffeine, and codeine

Name: Acetaminophen, butalbital, caffeine, and codeine

What is the most important information I should know about this medicine?

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

This medicine is not for use in children younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What should I avoid while taking this medicine?

Do not drink alcohol. Dangerous side effects or death could occur.

This medication may cause blurred vision and may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medication will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Acetaminophen, butalbital, caffeine, and codeine dosing information

Usual Adult Dose for Headache:

1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

For the Consumer

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

Along with its needed effects, acetaminophen / butalbital / caffeine / codeine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / butalbital / caffeine / codeine:

Less common
  • Confusion (mild)
  • mental depression
  • unusual excitement (mild)
Rare
  • Bleeding or crusting sores on the lips
  • chest pain
  • convulsions
  • fever with or without chills
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • hive-like swellings on the eyelids, face, lips, or tongue
  • hives, itching, or skin rash
  • muscle cramps or pain
  • red, thickened, or scaly skin
  • sores, ulcers, or white spots in the mouth
  • sore throat
  • swollen or painful glands
  • tightness in the chest
  • troubled breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / butalbital / caffeine / codeine:

Symptoms of overdose
  • Anxiety (severe)
  • cold and clammy skin
  • confusion (severe)
  • convulsions (seizures)
  • dizziness, lightheadedness, drowsiness, or weakness (severe)
  • excitement (severe)
  • increased sleepiness in babies (more than usual)
  • increased sweating
  • irritability (severe)
  • limpness (in babies)
  • nausea or vomiting
  • restlessness (severe)
  • slow, fast, or irregular heartbeat
  • slurred speech
  • stomach cramps or pain
  • swelling, pain, or tenderness in the upper abdomen or stomach area
  • trembling or shaking of the hands or feet
  • trouble sleeping (severe)
  • unusually slow or troubled breathing

Some side effects of acetaminophen / butalbital / caffeine / codeine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bloated or "gassy" feeling
  • dizziness or lightheadedness (mild)
  • drowsiness (mild)
  • nausea
  • stomach pain (mild)
  • vomiting

For Healthcare Professionals

Applies to acetaminophen / butalbital / caffeine / codeine: oral capsule

General

The most frequently reported adverse events have included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.[Ref]

Hepatic

Acetaminophen:
Frequency not reported: Liver failure[Ref]

Acute liver failure has been reported with acetaminophen use; many cases have been associated with use at doses in excess of 4 g/day, and often involving more than 1 acetaminophen-containing product.[Ref]

Respiratory

Common (1% to 10%): Shortness of breath
Uncommon (0.1% to 1%): Nasal congestion

Codeine:
Postmarketing reports: Respiratory depression including deaths[Ref]

Respiratory depression resulting in death has been reported in children who received codeine postoperatively following tonsillectomy and/or adenoidectomy. These children had evidence of being ultra-rapid metabolizers of codeine. Death has also been reported in nursing infants exposed to high levels of morphine in breast milk due to their breastfeeding mother being an ultra-rapid metabolizer of codeine.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reactions
Postmarketing reports: Anaphylaxis

Acetaminophen:
Postmarketing reports: Anaphylaxis[Ref]

Dermatologic

Several cases of dermatologic reactions including toxic epidermal necrolysis and erythema multiforme have been reported with butalbital/acetaminophen/caffeine.[Ref]

Butalbital/Acetaminophen/Caffeine/Codeine:
Uncommon (0.1% to 1%): Hyperhidrosis, pruritus
Frequency not reported: Toxic epidermal necrolysis, erythema multiforme

Acetaminophen:
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
Frequency not reported: Rash[Ref]

Psychiatric

Butalbital/Acetaminophen/Caffeine/Codeine:
Uncommon (0.1% to 1%): Agitation, euphoria

Caffeine:
Frequency not reported: Irritability, dependence[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain
Uncommon (0.1% to 1%): Dry mouth, difficulty swallowing, heartburn, flatulence, constipation[Ref]

Renal

Butalbital/Acetaminophen/Caffeine/Codeine:
Uncommon (0.1% to 1%): Diuresis

Caffeine:
Frequency not reported: Nephrotoxicity[Ref]

Hematologic

Acetaminophen:
Frequency not reported: Thrombocytopenia, agranulocytosis[Ref]

Cardiovascular

Butalbital/Acetaminophen/Caffeine/Codeine:
Uncommon (0.1% to 1%): Tachycardia

Caffeine:
Frequency not reported: Cardiac stimulation[Ref]

Nervous system

Butalbital/Acetaminophen/Caffeine/Codeine:
Common (1% to 10%): Drowsiness, lightheadedness, dizziness, sedation
Uncommon (0.1% to 1%): Headache, shaky feeling, tingly, fainting, numbness, seizures, mental confusion, excitement or depression due to intolerance

Caffeine:
Frequency not reported: Tremor

Opioids:
Frequency not reported: Serotonin syndrome (with concomitant serotonergic drugs)[Ref]

Other

Common (1% to 10%): Intoxicated feeling
Uncommon (0.1% to 1%): Fatigue, high energy, heavy eyelids, sluggishness, hot spells, fever, earache, tinnitus

Metabolic

Caffeine:
Frequency not reported: Hyperglycemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain, muscle fatigue[Ref]

Endocrine

Opioids:
Frequency not reported: Adrenal insufficiency, androgen deficiency

Some side effects of acetaminophen / butalbital / caffeine / codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Headache

1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Dose Adjustments

Use with caution

Acetaminophen / butalbital / caffeine / codeine Pregnancy Warnings

Use is not recommended unless clearly needed US FDA pregnancy category: C Comment: -Monitor for barbiturate withdrawal in neonates -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Animal reproduction studies have not been conducted on this combination product. Epidemiologic data for acetaminophen, including a population based case-control study from the National Birth Defects Prevention Study (n= 11,610) and data from 26,424 live singleton births have shown no increased risk of major birth defects in children with first trimester prenatal exposure. In 2015, the US Food and Drug Administration released results of their evaluation on published research studies looking at mothers who took acetaminophen (either over the counter or as a prescription product) at any time during their pregnancy and the risk of attention deficit hyperactivity (ADHD) in their babies. They found all studies reviewed had potential limitations in their designs that prevented drawing reliable conclusions. Barbiturates have been reported to readily cross the placental barrier. A 2-day old infant whose mother had taken a butalbital-containing product during the last two months of pregnancy experienced withdrawal seizures; butalbital was found in the infant's serum. Codeine may lead to respiratory depression in the neonate. There are no controlled data in human pregnancy. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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