Adult Dosing

Mild to moderate pains (Arthriten, Excedrin Extra Strength, Goody's Extra Strength, Pamprin Max)

• 2 Tabs PO qid
• Max: 8 tabs/day

Mild to moderate pains (Excedrin Menstrual Complete)

• 2 Gelcaps PO qid
• Max: 8 gelcaps/day

Mild to moderate pains (Goody's Powder Cool Orange, Goody's Powder Extra Strength)

• Place 1 Pwdr on tongue qid
• Max: 4 pwdrs/day

Migraine

• 2 tabs PO qd
• Max: 2 tabs/day

Note:

• To be taken with a full glass of water

Pediatric Dosing

• Safety and effectiveness for migraine headaches have not been established in pediatric patients

Mild to moderate pains (>12 yrs) (Excedrin Extra Strength, Goody's Extra Strength, Pamprin Max)

• 2 Tabs PO qid
• Max: 8 tabs/day

Mild to moderate pains (>12 yrs) (Excedrin Menstrual Complete)

• 2 Gelcaps PO qid
• Max: 8 gelcaps/day

Mild to moderate pains (>12 yrs) (Goody's Powder Cool Orange, Goody's Powder Extra Strength)

• Place 1 Pwdr on tongue qid
• Max: 4 pwdrs/day

Note:

• To be taken with a full glass of water

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporarily relieves mild to moderate pains caused due to headache, toothache, muscular aches, arthritis, menstrual cramps, or a cold
• Treatment of migraine [Excedrin Migraine]

• Hypersensitivity to any of the ingredients of the product
• Co-administration with any other drug containing acetaminophen

• N/A

Renal Dose Adjustment

• Severe renal impairment: Avoid use
• Mild-moderate renal impairment: Decrease dose, exact dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Severe hepatic impairment: Avoid use
• Mild-moderate hepatic impairment: Decrease dose, exact dose adjustments not defined; caution advised

• Aspirin can cause Reye's syndrome, a rare but serious illness, when used in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. If changes in behavior with nausea and vomiting occur, discontinue the drug and provide appropriate therapy as these symptoms could be an early sign of Reye’s syndrome
• Severe allergic reactions including facial swelling, hives, rash, asthma, shock and skin reddening are associated with aspirin use. Discontinue the treatment at the first appearance of skin rash or any other sign of hypersensitivity like anaphylactoid reactions
• Severe liver damage may occur with exceeding recommended dosages or concomitant use of other drugs containing acetaminophen or having 3 or more alcoholic drinks every day while continuing therapy. Avoid concomitant use with any other drugs containing acetaminophen
• NSAIDs may cause severe stomach bleeding. Factors increasing this risk include: Age 60 yrs and above, blood thinning (anticoagulant) or steroid drug, concomitant use of other drugs containing prescription or nonprescription NSAIDs, stomach ulcers or bleeding problems, 3 or more alcoholic drinks every day during therapy, or taking this drug for a prolonged period
• Caffeine overdose may cause nervousness, irritability, sleeplessness, and occasionally rapid heart beat. Hence, limit the use of caffeine-containing medications, foods, or beverages while taking this drug
• Advise patients to stop the use of this product and inform their physicians if they experience blood vomit, bloody or black stools, worsening stomach pain, redness or swelling, ringing in the ears or loss of hearing, or if the pain gets worse

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Peptic ulcer disease
• GI bleed
• Liver cirrhosis
• Use of anticoagulant
• Hypertension
• Cardiac disease
• Diuretic use
• Asthma
• Concomitant treatment of diabetes mellitus
• Concomitant treatment of gout
• Concomitant treatment of arthritis
• Chronic alcohol abuse
• Coagulation disorder
• Elderly patients

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

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. It is best to avoid aspirin during breastfeeding, especially with very young infants. As per some expert opinion, low dose of aspirin (75-162 mg/day) can be used as an antiplatelet drug in nursing mothers; chronic high dose should be avoided. Avoid breastfeeding for 1 to 2 hours after a dose, if aspirin is to be taken in order to minimize antiplatelet effects in the infant. The risk of Reye's syndrome caused by salicylate in breastmilk is unknown. Caffeine is excreted in breastmilk rapidly after maternal ingestion. High intake of caffeine equivalent to about 10 or more cups of coffee daily by mother causes fussiness, jitteriness and poor sleep patterns in infants. No stimulatory effects on infants 3 wks were observed in mothers taking 5 cups of coffee daily. Preterm and younger newborn infants metabolize caffeine very slowly and may have serum levels of caffeine and other active caffeine metabolites similar to their mothers'. Decreased breast milk iron concentrations and mild iron deficiency anemia in some breastfed infants may occur on intake of >450 mL of coffee daily. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 9 April 2011). Maternal medication with acetaminophen is usually compatible with breastfeeding; no observable change was seen in the nursing infant while the mother was ingesting the compound. Based on data from AAP Policy Guidelines, irritability and poor sleeping pattern may occur as caffeine is excreted slowly. No effects were observed with moderate intake of caffeinated beverages (2-3 cups per day). Available at (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 9 April 2011).

• GI: Hepatotoxicity, nausea, vomiting, abdominal pain, GI ulceration/perforation, GI bleed, dyspepsia, pancreatitis, constipation, diarrhea, necrotizing enterocolitis, gastritis
• CV: Tachycardia, hypotension, arrhythmias
• CNS: Weakness, headache, dizziness, seizures, confusion, agitation, lethargy, cerebral hemorrhage, irritability, restlessness, insomnia, cerebral edema, coma
• GU: Renal failure, acute renal tubular necrosis, chronic analgesic nephropathy, nephrotoxicity
• HEMA: Thrombocytopenia, prolonged bleeding time, DIC, pancytopenia, agranulocytosis, aplastic anemia, hypoprothrombinemia, ecchymosis
• METABOLIC: Dehydration, hyperkalemia, metabolic acidosis, respiratory acidosis, hyperuricemia
• EENT: Tinnitus, retinopathy, hearing loss
• RESP: Pulmonary edema, dyspnea
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, angioedema, bronchospasm, photosensitivity, asthma, laryngeal edema, urticaria
• MUSC: Rhabdomyolysis
• DERM: Rash, dry skin, skin atrophy
• MISC: Reye syndrome, fever, hypothermia, thirst, abnormal healing, sepsis, salicylism

Acetaminophen

• Analgesic, antipyretic; acts primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis; reduces fever through direct action on hypothalamic heat-regulating centers
• Rapid and almost complete absorption
• Metabolized in the liver; CYP450: CYP2E1, CYP1A2
• Excreted in urine (5-10% unchanged)
• Half-life: 2-4 hrs

Aspirin

• Platelet aggregation inhibitor/cyclooxygenase inhibitor; inhibits the activity of COX-1 and COX-2 enzymes, thus decreasing the formation of precursors of prostaglandins and thromboxanes from arachidonic acid and also irreversibly inhibits the platelet aggregation
• Rapidly and completely absorbed following oral administration
• Metabolized primarily in the liver to salicylic acid
• Renally excreted (amount excreted unchanged is pH dependent)
• Half-life
• aspirin: 15-20 minutes
• Salicylic acid: 2-6 hrs (dose dependent)

Caffeine

• CNS stimulants; precise mechanism of action unknown; stimulates medullary, vagal, vasomotor, and respiratory centers, promoting bradycardia, vasoconstriction, and increased respiratory rate; antagonizes adenosine A1 and A2 receptors
• Rapidly absorbed
• Metabolized in the liver; CYP450: CYP1A2
• Excreted in urine (1% unchanged)
• Half-life: Adults 3-7 hrs; infants 3-4 days

US Trade Name(s)

• Arthriten
• Bayer Migraine Formula
• Excedrin Extra Strength
• Excedrin Menstrual Complete
• Excedrin Migraine
• Goody's Extra Strength
• Goody's Migraine Relief
• Goody's Powder Cool Orange
• Goody's Powder Extra Strength
• Pamprin Max

US Availability

acetaminophen/aspirin/caffeine (generic)

• OTC TABS: 250 mg/250 mg/65 mg

Bayer Migraine Formula, Excedrin Migraine, Goody's Migraine Relief (acetaminophen/aspirin/caffeine)

• OTC TABS: 250 mg/250 mg/65 mg

Arthriten, Excedrin Extra Strength, Goody's Extra Strength, Pamprin Max (acetaminophen/aspirin/caffeine)

• OTC TABS: 250 mg/250 mg/65 mg

Excedrin Menstrual Complete (acetaminophen/aspirin/caffeine)

• OTC GELCAPS: 250 mg/250 mg/65 mg

Goody's Powder Extra Strength (acetaminophen/aspirin/caffeine)

• OTC PWDR: 260 mg/500 mg/32.5 mg

Goody's Powder Cool Orange (acetaminophen/aspirin/caffeine)

• OTC PWDR: 325 mg/500 mg/65 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Anadin Extra
• Boots Aspirin Extra

UK Availability

Anadin Extra (acetaminophen/aspirin/caffeine)

• TABS: 200 mg/300 mg/45 mg

Boots Aspirin Extra (acetaminophen/aspirin/caffeine)

• TABS: 200 mg/300 mg/45 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Analgesics

Analgesics; Combinations

Pricing data from www.DrugStore.com in U.S.A.

• Excedrin Extra Strength 250-250-65 MG TABS [Bottle] (NOVARTIS)
  50 mg = $15.99
  100 mg = $21.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet (Target Corporation)
• APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet (Topco Associates LLC)
• Excedrin Migraine (acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG) Oral Tablet (Novartis Consumer Health, Inc.)