Acetaminophen-Aspirin-Caffeine

Acetaminophen-Aspirin-Caffeine is an over-the-counter (OTC) medication used for relieving pain associated with migraine. 

• Acetaminophen-Aspirin-Caffeine is available under the following different brand names: Excedrin Extra Strength, Vanquish, Bayer Migraine Formula, Excedrin Migraine, Excedrin Menstrual Complete, Goody's Extra Strength Fast Pain Relief Powders, Goody's Extra Strength, Goody's Extra Strength Headache Powders, Goody's Migraine Relief, Anacin Advanced Headache, Arthriten, Pamprin Max

Adult dosage

Tablet/Capsule

• 194 mg /227 mg /33 mg
• 250 mg /250 mg /65 mg 
• 260 mg /520 mg/ 32.5 mg
• 325 mg /500 mg /65 mg

Pain, Migraine

Adult dosage

• 1-2 capsules or tablets orally every 4-6 hours or as needed

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Acetaminophen-Aspirin-Caffeine include:

• nausea, 
• vomiting,
• stomach upset, 
• trouble falling asleep, or
• a shaky/nervous feeling.

Serious side effects of Acetaminophen-Aspirin-Caffeine include:

• severe stomach/abdominal pain,
• severe dizziness,
• fainting,
• vomit that looks like coffee grounds, 
• black/bloody stools,
• ringing in the ears, 
• loss of hearing,
• irregular/fast heartbeat,
• signs of kidney problems (such as a change in the amount of urine),
• signs of infection (such as sore throat that doesn't go away or fever), 
• easy bruising/bleeding

Rare side effects of Acetaminophen-Aspirin-Caffeine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acetaminophen-Aspirin-Caffeine has severe interactions with the following drugs:
  • abrocitinib
  • dichlorphenamide
  • isocarboxazid
  • linezolid
  • mifepristone
  • phenelzine
• Acetaminophen-Aspirin-Caffeine has serious interactions with at least 29 other drugs.
• Acetaminophen-Aspirin-Caffeine has moderate interactions with at least 436 other drugs.
• Acetaminophen-Aspirin-Caffeine has minor interactions with at least 206 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Hepatitis or severe hepatic or renal impairment
• Repeated administration in patients with anemia or with cardiac, pulmonary, or renal disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Aspirin-Caffeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen-Aspirin-Caffeine?”

Cautions

• Risk of hepatotoxicity (higher in alcoholics and with use of above 1 acetaminophen-containing product)
• If pregnant or breast-feeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless directed to do so by a doctor; may cause problems in the unborn child or complications during delivery
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Gastrointestinal (GI) bleeding; exercise particular caution in patients with a history of GI bleeding, alcoholism, or bleeding disorders
• Avoid with active peptic ulcer disease
• Avoid with severe renal impairment (i.e., CrCl is less than10 mL/min)
• Avoid with severe hepatic impairment
• Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters, and rash
• Headaches may worsen if this product is used for more than 10 days per month (i.e., medication overuse headache)

Pregnancy and Lactation

• Avoid chronic or intermittent high doses of aspirin during pregnancy; may affect maternal and newborn hemostasis mechanisms, leading to an increased risk of hemorrhage
• High doses of aspirin may also increase perinatal mortality by intrauterine growth restriction and teratogenic effects
• Near term, aspirin may prolong gestation and labor
• Premature closure of the ductus arteriosus may occur if used near term with the use of full-dose aspirin
• Seek the advice of a health professional before using OTC drugs during pregnancy
• Lactation
  • The drug enters breast milk; a decision should be made regarding whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
  • Seek the advice of a health professional before using OTC drugs while breastfeeding