MEDICATION GUIDE

• 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.

• Get emergency help or call 911 right away if you take too much Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP (overdose) . When you first start taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 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. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
  
• Taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or gregabalin), 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 Capsules, USP. They could die from taking it. Selling or giving away Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP is against the law.
  
• Store Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

• Do not give Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP to a child younger than 12 years of age.
  
• Do not give Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP 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.

• 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)

• head injury, seizures
  
• liver, kidney, thyroid problems
  
• problems urinating
  
• pancreas or gallbladder problems
  
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.      
  
• have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines

• noticing your pain getting worse. If your pain gets worse after you take Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, do not take more of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP.
  
• are pregnant or planning to become pregnant. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP may harm your baby. Use of Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP 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.
  
• are breastfeeding. Not recommended; may harm your baby.
  
• d evelop any type of rash or fever. Contact your healthcare provider as soon as possible and stop taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP.
  
• are living in a household where there are small children or someone who has abused street or prescription drugs
  
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP with certain other medicines can cause serious side effects that could lead to death.

• Do not change your dose. Take Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP for a few days. You may have some Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP.
  
• Take your prescribed dose of 1 or 2 capsules every 4 hours at the same time every day 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 Capsules, USP regularly, do not stop taking Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP without talking to your healthcare provider.
  
• Dispose of expired, unwanted, or unused Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP 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.

• Drive or operate heavy machinery, until you know how Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP affects you. Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP 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 Capsules, USP may cause you to overdose and die.

• 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.

• 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 Capsules, USP 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 Capsules, USP. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured by:

LGM Pharma Solutions, LLC

Irvine, CA 92614

6094-PD

Rev 11/2025