Adult Dosing

Minor body aches and pains

• Excedrin Back & Body
• 2 tabs [500 mg/500 mg] PO q6 hrs PRN; drink a full glass of water with each dose
• Max: 8 tabs/day

• Goody’s Back & Body Pain
• Place one pwdr [325 mg/500 mg] on tongue q6 hrs PRN; drink a full glass of water with each dose
• Alt: Stir pwdr [325 mg/500 mg] into a glass of water/other liquid q6 hrs PRN
• Max: 4 doses/24 hrs

Pediatric Dosing

• Safety and effectiveness in pediatric patients <12 yrs have not been established

Minor body aches and pains

• Excedrin Back & Body (12 yrs)
• 2 tabs [500 mg/500 mg] PO q6 hrs PRN; drink a full glass of water with each dose
• Max: 8 tabs/day

• Goody's Back & Body Pain (12 yrs)
• Place one pwdr [325 mg/500 mg] on tongue q6 hrs PRN; drink a full glass of water with each dose
• Alt: Stir pwdr [325 mg/500 mg] into a glass of water/other liquid q6 hrs PRN
• Max: 4 doses/24 hrs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of minor aches and pains associated with muscular aches, arthritis, backache, cold and headache
• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Co-administration with any other drug containing acetaminophen
• Aspirin or NSAID-induced asthma or urticaria
• Aspirin triad
• Coagulation disorder
• GI bleed
• G6PD deficiency
• Uncontrolled or severe hypertension
• Influenza, varicella, or febrile viral infections (patients <20 yrs)

• N/A

Renal Dose Adjustment (Based on CrCl)

• Acetaminophen
• 10-50 mL/min: give q6 hrs
• <10 (mL/min): give q8 hrs

• Aspirin
• <10 mL/min: Avoid use
• Mild-moderate renal impairment: Caution advised; dose adjustments not defined

Hepatic Dose Adjustment

• Acetaminophen
• Hepatic impairment: Consider dose reduction; dose adjustments not defined

• Aspirin
• Severe hepatic impairment: Avoid use
• Mild-moderate hepatic impairment: Caution advised; dose adjustments not defined

See Supplemental Patient Information

• Potential for development of Reye’s syndrome, a rare but serious illness, exists with aspirin; avoid use of this product in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Advise patients/caregivers to consult a physician if they observe changes in behavior with nausea and vomiting during therapy
• Aspirin component of this combination drug may cause a severe allergic reaction including hives, facial swelling, asthma (wheezing), and shock
• Overdosage of this product may cause severe liver damage, which may occur on exceeding recommended dosages, concomitant use with other drugs containing acetaminophen, or on consuming 3 or more alcoholic drinks every day while receiving therapy. Avoid concomitant use with any other drugs containing acetaminophen
• NSAIDs may cause severe stomach bleeding; this risk is higher in patients 60yrs, having a history of stomach ulcers or bleeding problems, receiving treatment with anticoagulants or steroid drug, using other drugs containing prescription or nonprescription NSAIDs, consuming 3 alcoholic drinks/day, and those exceeding recommended dosages
• Before initiating therapy, obtain a detailed medical history for the presence of stomach/cardiovascular/renal/hepatic/respiratory/bleeding/thyroid/prostate disorders
• Discontinue therapy and consult a clinician if blood vomit occurs, bloody or black stools occur, redness or swelling is noted, an allergic reaction occurs, pain gets worse or lasts more than 10 days, fever lasts >3 days, ringing in ears or loss of hearing occurs, or if new symptoms appear; further evaluate the patients as these could be signs of a serious condition
• Aspirin component of this combination drug is associated with fetal harm and complications during delivery; avoid use of this combination drug in the last trimester of pregnancy unless it is deemed important to the mothers

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• History of stomach problem (such as heartburn)
• Hypertension
• Diuretic use
• Asthma
• Use of anticoagulant
• Diabetes mellitus
• Gout
• Arthritis
• Chronic alcohol abuse
• GERD
• History of GI bleeding
• Severe hypovolemia
• Liver cirrhosis
• Chronic malnutrition
• PKU (phenylalanine-containing forms)
• Peptic ulcer disease
• Increased intracranial pressure
• Intracranial lesion
• Sodium-restricted diet
• Surgery or trauma
• Thrombocytopenia

Supplemental Patient Information

• Advise patients to consult their physician if symptoms do not improve in 10 days, if new symptoms occur, or if fever gets worse or lasts more than 3 days
• Instruct patients to avoid alcoholic beverages during therapy
• Instruct patients to inform their clinician if they are pregnant or breast-feeding prior to initiating therapy

Pregnancy Category:B (acetaminophen), D (aspirin)

Breastfeeding: Acetaminophen is a good choice for analgesia and fever reduction in nursing mothers. Amounts excreted in milk are much less than doses usually given to infants. Adverse effects in breastfed infants appear to be rare. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 August 2011). Maternal medication is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. This information is based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776/T6 last accessed 31 August 2011). It is best to avoid aspirin during breastfeeding, especially with very young infants. As per some expert opinion, low dose aspirin (75-162 mg/day) may be used as an antiplatelet drug in nursing mothers; avoid chronic, high-dose aspirin. Avoid breastfeeding for 1-2 hours after a dose of aspirin to minimize antiplatelet effects in the infant. The risk of Reye's syndrome caused by salicylate in breastmilk is unknown. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 31 August 2011).

• CNS: Headache, dizziness
• EENT: Tinnitus
• HYPERSENSITIVITY: Allergic reaction (redness, hives, facial swelling, asthma, shock), anaphylactic/anaphylactoid reactions, angioedema
• GI: Stomach bleeding, abdominal pain, GI ulceration/perforation, hepatotoxicity, constipation, diarrhea, dyspepsia, nausea, vomiting
• GU: Nephrotoxicity, chronic analgesic nephropathy, acute renal tubular necrosis
• HEMA: Agranulocytosis, aplastic anemia, anemia, bleeding, DIC, hypoprothrombinemia, pancytopenia, thrombocytopenia, hyperuricemia
• RESP: Bronchospasm
• DERM: Ecchymosis, rash
• MISC: Reye's syndrome, salicylism

Acetaminophen

• Analgesic, antipyretic; acts primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1 and COX-2, enzymes involved in prostaglandin (PG) synthesis; reduces fever through direct action on hypothalamic heat-regulating center
• Rapid and almost complete absorption
• Metabolized by liver; CYP450: 2E1, 1A2
• Excreted in urine 85% (5-10% unchanged)
• Half-life: 1.25-3 hrs

Aspirin

• Platelet aggregation inhibitor; inhibits prostaglandin synthesis, exhibits analgesic, anti-inflammatory activity; inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thereby inhibiting the generation of thromboxane A2
• Rapidly and completely absorbed following oral administration
• Hydrolyzed in gut plasma (aspirin) and metabolized by liver (salicylic acid); CYP450: Unknown
• Excreted in urine
• Half-life: 15-20 minutes (aspirin), 2-6 hrs (salicylic acid)

US Trade Name(s)

• Excedrin Back & Body
• Goody's Back & Body Pain

US Availability

Excedrin Back & Body (acetaminophen/aspirin)

• OTC TAB: 250 mg/250 mg

Goody's Back & Body Pain (acetaminophen/aspirin)

• OTC PWDR: 325 mg/500 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Analgesics; Combinations