Classes
DEA Class; OTC
Common Brand Names; Goody’s Powder Back & Body Pain, Excedrin Back & Body
Analgesic and other combo
Description
Oral combination of analgesics
Used for the treatment of fever and minor aches and pains due to headache, arthritis, muscular aches, or colds
Not to exceed maximum recommended daily dose of acetaminophen, including acetaminophen-containing combination products, due to risk for hepatotoxicity
Uses/Indications
Indicated to relieve minor pain caused by headache, muscular aches, fever, minor arthritis pain, and colds
Contraindications
Hypersensitivity
Hepatitis or severe hepatic/renal impairment
Adverse Effects
Acetaminophen
Angioedema, laryngeal edema
Pruritic maculopapular rash, urticaria
Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
Hepatotoxicity
May increase uric acid, chloride, glucose
May decrease sodium, calcium, bicarbonate
Anaphylactoid reaction
Aspirin
Rash, urticaria
Dyspepsia, heartburn, nausea, stomach pain, vomiting
Tinnitus (high or chronic dose)
Warnings
Contains aspirin; children and adolescents should not use for symptoms of viral infections (eg, chickenpox, influenza) due to risk for Reye syndrome
Hepatic impairment or consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen) or GI bleeding (associated with magnesium salicylate)
Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose
Avoid with active peptic ulcer disease
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
Pregnancy and Lactation
Pregnancy Category: D; avoid aspirin (NSAIDs) during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus
Lactation: Excreted in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Adults
Acetaminophen 1,300 mg/day PO and aspirin 2,000 mg/day PO.
Geriatric
Acetaminophen 1,300 mg/day PO and aspirin 2,000 mg/day PO.
Adolescents
Acetaminophen 1,300 mg/day PO and aspirin 2,000 mg/day PO.
Children
Children 12 years: Acetaminophen 1,300 mg/day PO and aspirin 2,000 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
Oral powder (Goody’s Powder Back & Body Pain)
325mg/500 mg
Caplet (Excedrin Back & Body)
250mg/250mg