Paracetamol/Aspirin/Caffeine

DEA Class;  OTC

Common Brand Names; Bayer Migraine Formula, BC MAX STRENGTH Fast Pain Relief, Excedrin Extra Strength

Analgesic and other combo

Combinations product used for HA (including migraine), sinus congestion pain, myalgia, dysmenorrhea, dental pain, and minor arthritis pain.

Acetaminophen is a non-narcotic analgesic; aspirin is a salicylate analgesic.

Caffeine may increase the bioavailability of certain analgesics but does not have intrinsic analgesic properties.

Used for the temporary relief of mild pain to moderate pain associated with arthralgia, dental pain, dysmenorrhea, headache, myalgia, and/or premenstrual or menstrual cramps.

For the acute treatment of migraine.

Hypersensitivity

Hepatitis or severe hepatic or renal impairment

Repeated administration in patients with anemia or with cardiac, pulmonary, or renal disease

Acetaminophen

Angioedema, laryngeal edema

Pruritic maculopapular rash, urticaria

Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura

Hepatotoxicity

Anaphylactoid reaction

Aspirin

Rash, urticaria

Dyspepsia, heartburn, nausea, stomach pain, vomiting

Tinnitus (high dose or long-term use)

Caffeine

Palpitations (dose dependent), tachycardia

Insomnia, restlessness, nervousness, tremor, irritability

Diarrhea, nausea, vomiting

Diuresis

Tinnitus

Risk of hepatotoxicity (higher in alcoholics and with use of >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 definitely 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 history of GI bleeding, alcoholism, or bleeding disorders

Avoid with active peptic ulcer disease

Avoid with severe renal 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 ≥10 days per month (ie, medication overuse headache)

Pregnancy

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

Lactation: Drug enters breast milk; a decision should be made regarding whether to discontinue nursing or to discontinue drug, taking into account importance of drug to mother

Seek advice of health professional before using OTC drugs while breastfeeding

Adults

Acetaminophen 4000 mg/day PO; aspirin 2080 mg/day PO; caffeine 520 mg/day PO.

Geriatric

Acetaminophen 4000 mg/day PO; aspirin 2080 mg/day PO; caffeine 520 mg/day PO.

Adolescents

Acetaminophen 4000 mg/day PO; aspirin 2080 mg/day PO; caffeine 520 mg/day PO.

Children

>= 12 years: Acetaminophen 4000 mg/day PO; aspirin 2080 mg/day PO; caffeine 520 mg/day PO.

< 12 years: Safety and efficacy have not been established.

acetaminophen/aspirin/caffeine

Tablet/Capsule

194mg/227mg/33mg

250mg/250mg/65mg

260mg/520mg/32.5mg

325mg/500mg/65mg