BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE - butalbital, aspirin, caffeine and codeine phosphate capsule 
Amneal Pharmaceuticals of New York, LLC

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This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: 01/2024

Medication Guide
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE capsules
BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is indicated for the relief of the symptom complex of tension (or muscle contraction) headache, 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 BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE:
  • Get emergency help or call 911 right away if you take too much BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE (overdose). When you first start taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE, 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
  • Taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE 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 BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. They could die from taking it. Selling or giving away BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE is against the law.
  • Store BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Important Information Guiding Use in Pediatric Patients:
  • Do not give BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE to a child younger than 12 years of age.
  • Do not give BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
  • Avoid giving BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
Do not give BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE to a child or teenager with a viral illness. Reye's syndrome, a life-threatening condition, can happen when aspirin (an ingredient in BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE) is used in children and teenagers who have certain viral illnesses.

Do not take BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
  • known allergy to nonsteroidal anti-inflammatory drug products (NSAIDs)
  • a rare disorder in which your blood doesn't clot normally (hemophilia)
Before taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, opiod overdose or mental health problems.
  • have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines
Tell your healthcare provider if you:
  • notice your pain getting worse. If your pain gets worse after you take BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE, do not take more of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE.
  • are pregnant or planning to become pregnant. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE may harm your baby. Use of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Taking NSAID-containing products like BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy.
  • breast-feeding. Not recommended; may harm your baby.
  • develop any type of rash or fever. Contact your healthcare provider as soon as possible and stop taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE.
  • living in a household where there are small children or someone who has abused street or prescription drugs
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE with certain other medicines can cause serious side effects that could lead to death.
When taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE:
  • Do not change your dose. Take BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • For acute (short-term) pain, you may only need to take BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE for a few days. You may have some BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE.
  • Take your prescribed dose of 1 or 2 capsules every 4 hours as needed for pain. Total daily dosage should not exceed 6 capsules. 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 BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE regularly, do not stop taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE without talking to your healthcare provider. Dispose of expired, unwanted, or unused BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE by taking your drug to an authorized DEA- registered collector or drug take-back program. If one is not available, you can dispose of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE DO NOT:
  • Drive or operate heavy machinery, until you know how BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE affects you. BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE may cause you to overdose and die.
The possible side effects of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, rash, or fever. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
  • If you are a nursing mother taking BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.
    These are not all the possible side effects of BUTALBITAL, ASPIRIN, CAFFEINE and CODEINE PHOSPHATE. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716
Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Revised: 1/2024
Amneal Pharmaceuticals of New York, LLC