Classes
DEA Class; OTC
Common Brand Names; Anacin, Aspircaf, Bayer Extra Strength Back and Body
Analgesic and other combo
Description
Oral combination of a salicylate, nonsteroidal antiinflammatory drug and methylxanthine analeptic
Used for the treatment of fever, temporary relief of minor aches and pains, and to help restore mental alertness when experiencing fatigue
Limit use of additional caffeine-containing drugs, foods, or drinks
Uses/Indications
Indicated for temporary relief of minor aches and pains associated with a hangover, helps restore mental alertness or wakefulness when fatigue or drowsiness is associated with a hangover (also indicated for headaches and other mild analgesic needs)
Used for the treatment of fever and mild pain due to arthralgia, backache, dental pain, dysmenorrhea, headache, myalgia, or colds.
Contraindications
Aspirin is contraindicated in patients with salicylate hypersensitivity or NSAID hypersensitivity. Aspirin is also contraindicated in patients with the syndrome of asthma, rhinitis, and nasal polyps; aspirin may cause severe urticaria, angioedema, or bronchospasm in these patients.
Aspirin is contraindicated in children for viral infection, with or without fever, because of the risks of Reye’s syndrome. Do not use aspirin in children recovering from varicella infection or influenza.
Adverse Effects
Seizures
Coma
Hearing loss
Cerebral edema
GI bleeding
Peptic ulcer
Reye’s syndrome
Interstitial nephritis
Renal failure
Intracranial bleeding
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Anxiety
Confusion
Warnings
Avoid aspirin; caffeine in patients with active peptic ulcer disease due to the risk for gastric ulceration and bleeding.
Use aspirin; caffeine with caution in patients with cardiac disease or hypertension.
Avoid aspirin in patients with severe hepatic insufficiency. Hepatic disease increases the risk for bleeding.
Pregnancy and Lactation
Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus
Lactation: Excreted in breast milk; do not breast feed
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Adults
Adults 60 to 64 years: Aspirin 4,000 mg/day and caffeine 260 mg/day PO.
Adults 18 to 59 years: Aspirin 4,000 mg/day and caffeine 480 mg/day PO.
Geriatric
Aspirin 4,000 mg/day and caffeine 260 mg/day PO.
Adolescents
Aspirin 4,000 mg/day and caffeine 480 mg/day PO.
Children
Children 12 to 17 years: Aspirin 4,000 mg/day and caffeine 480 mg/day PO.
Children 1 to 11 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
How supplied
Tablet
250mg/65mg
400mg/32mg
500mg/32mg
500mg/32.5mg
Caplet
250mg/65mg
500mg/65mg
Powder
845mg/65mg
1000mg/65mg
Quick release crystals
850mg/65mg