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The following provides critical safety information and warnings for the use of Fioricet with Codeine. Please review these details carefully and consult your healthcare provider with any questions or concerns.

• Risk of Addiction, Abuse, and Misuse: Fioricet with Codeine can be habit-forming, even at prescribed doses, potentially leading to abuse, addiction, overdose, and death. Due to these risks, this medication is part of the FDA's Risk Evaluation and Mitigation Strategy (REMS) program. Discuss proper usage, risks, and safe storage and disposal with your healthcare provider. Risks are higher for individuals with a history of substance or alcohol abuse, mental health conditions, or those using the medication beyond prescribed amounts.

• Breathing Problems in Adults: Fioricet with Codeine may cause life-threatening respiratory depression. If you experience symptoms like shortness of breath, wheezing, or confusion, seek emergency help immediately. This risk is especially high during initial treatment or dosage increases. Risks increase when combined with alcohol, other medications affecting breathing, acute or severe asthma, COPD, or in older or frail individuals.

• Breathing Issues in Children: Life-threatening respiratory issues can occur in children, particularly those under 12 or those aged 12 to 18 after certain surgeries. Discuss the risks and benefits with your child's healthcare provider and use the lowest effective dose for the shortest time. Seek immediate medical help if symptoms like wheezing or confusion occur. Children with specific genetic profiles, obesity, or severe lung conditions are at higher risk.

• Accidental Overdose: Exceeding the recommended dose can result in a fatal overdose, especially in children. Limit intake to no more than 6 capsules per day. Signs of overdose include slowed breathing and unresponsiveness. Emergency medical help is essential if an overdose is suspected.

• Impaired Brain Function: Combining Fioricet with Codeine with alcohol or medications like benzodiazepines can severely depress brain activity, leading to extreme drowsiness, slowed breathing, coma, or death. Avoid tasks requiring alertness until you know how the medication affects you. Emergency assistance is crucial if severe symptoms appear.

• Withdrawal in Newborns: Prolonged use during pregnancy may lead to neonatal opioid withdrawal syndrome, which is life-threatening for newborns. Symptoms include irritability and breathing problems. Discuss the risks with your healthcare provider if pregnant or breastfeeding.

• Medication Interactions: Fioricet with Codeine interacts with numerous drugs, potentially altering their effects. Combining it with certain antibiotics or antifungals increases risk of respiratory issues, while other drugs may cause withdrawal symptoms. Consult healthcare professionals before making any medication changes.

• Liver Damage: Excessive acetaminophen (Tylenol) intake can cause liver failure. Avoid exceeding 4000 mg of acetaminophen daily, and be cautious with alcohol consumption. Discuss potential risks if you have liver disease.

• Cortisol Insufficiency: Long-term use can result in low cortisol levels, affecting mood, stress, and blood pressure. Report symptoms such as nausea or dizziness to your healthcare provider for appropriate testing and treatment.

• Low Blood Pressure: Fioricet with Codeine may cause significantly low blood pressure, particularly when standing, posing higher risks for those on antihypertensives or certain antipsychotics. Exercise caution when changing positions and seek help if symptoms of low blood pressure occur.

• Increased Brain Pressure: Use caution if you have a history of brain tumors or head injuries, as Fioricet with Codeine can increase brain pressure. Report excessive drowsiness or slowed breathing to your healthcare provider.

• Stomach Issues: Avoid Fioricet with Codeine if you have a history of stomach or intestinal blockages. Monitor for symptoms like abdominal pain or vomiting and consult your healthcare provider if they occur.

• Seizures: Codeine may heighten seizure risk in those with a history of seizures. Notify your healthcare provider if you experience worsened or uncontrolled seizures.

• Withdrawal Symptoms: Abruptly stopping Fioricet with Codeine can lead to withdrawal symptoms. Work with your provider to taper doses gradually. Inform them if you are on other opioids.

• Allergic Reactions: Be aware of potential serious skin or allergic reactions. Seek emergency help if symptoms like swelling or rash occur. Avoid use if allergic to acetaminophen.

• Serotonin Syndrome: Combining with serotonergic medications may cause life-threatening serotonin syndrome. Seek immediate help if symptoms of agitation or high blood pressure occur.

Contraindications: Do not use in children under 12 or those under 18 post-tonsil/adenoid surgery, individuals with severe breathing problems, acute asthma, recent MAOI use, intestinal blockages, or porphyria. Always consult your healthcare provider.

Common side effects:

• Drowsiness
• Lightheadedness
• Dizziness
• Shortness of breath
• Nausea
• Vomiting
• Stomach pain
• Feeling intoxicated

Less common but important to monitor:

• Headaches
• Shaking
• Tingling or numbness
• Agitation
• Fainting
• Tiredness
• Heavy eyelids
• High energy
• Seizures
• Depression
• Confusion
• Dry mouth
• Excessive sweating
• Difficulty swallowing
• Heartburn
• Gas
• Constipation
• Fast heart rate
• Leg or muscle pain
• Frequent urination
• Itching
• Fever
• Earache
• Ringing in the ears
• Stuffy nose

Serious side effects:

• Respiratory depression
• Cns depression
• Overdose symptoms
• Withdrawal symptoms
• Liver failure
• Adrenal insufficiency
• Low blood pressure
• Intestinal blockage
• Inflammation of the pancreas
• Serious skin reactions
• Serotonin syndrome
• Allergic reactions
• Seizures