Adult Dosing

Cold/flu symptoms, antipyretic

• Tylenol Cough & Sore Throat Daytime
• 2 tablespoons or 1000 mg/30 mg PO q6 hrs PRN
• Max: [4000 mg/120 mg]/day

• Do not administer more than directed. Shake well before use
• Use only enclosed dosing cup provided with this product; avoid using any other dosing device

Pediatric Dosing

Cold/flu symptoms, antipyretic

• Children's Tylenol Plus Cough & Sore Throat
• <36 lbs; <4yrs: Do not use
• 36-47 lbs; 4-5 yrs: 1 teaspoon or 160 mg/5 mg PO q4 hrs PRN
• Max: [800 mg/25 mg]/day
• 48-95 lbs; 6-11 yrs: 2 teaspoons or 320 mg/10 mg PO q4 hrs PRN
• Max: [1600 mg/50 mg]/day

• Children's Triaminic Cough & Sore Throat
• 4-5 yrs
• 1 teaspoon or 160 mg/5 mg PO q4 hrs PRN; Max: [800 mg/25 mg]/day
• 1 tab or 160 mg/5 mg PO q4 hrs PRN; Max: [800 mg/25 mg]/day
• 6-11 yrs
• 2 teaspoons or 320 mg/10 mg PO q4 hrs PRN; Max: [1600 mg/50 mg]/day
• 2 tabs or 320 mg/10 mg PO q4 hrs PRN; Max: [1600 mg/50 mg]/day

• PediaCare Children's Fever Reducer Plus Cough & Sore Throat
• <36 lbs; <4yrs: Do not use
• 36-47 lbs; 4-5 yrs: Do not use unless directed by a doctor
• 48-95 lbs; 6-11 yrs: 2 teaspoons or 320 mg/10 mg PO q4hrs PRN
• Max: [1600 mg/50 mg]/day

• Tylenol Cough & Sore Throat Daytime
• >12 yrs
• 2 tablespoons or 1000 mg/30 mg PO q6 hrs PRN
• Max: [4000 mg/120 mg]/day

• Do not administer more than directed. Shake well before use
• Use only enclosed dosing cup provided with this product; avoid using any other dosing device

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of cold/flu symptoms including minor aches and pains, headache, toothache, sore throat, and cough
• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of monoamine oxidase inhibitor (MAOI) or within 2 wks of stopping MAOI

• N/A

Renal Dose Adjustment (Based on CrCl)

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

• Dextromethorphan
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

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

• Dextromethorphan
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Discontinue therapy if sore throat becomes severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting; further evaluate the patient and provide appropriate therapy
• Patients taking a prescription MAOI should not consume product containing acetaminophen or for 2 weeks after stopping the MAOI drug
• Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is noted, pain/cough/nasal congestion gets worse or lasts more than 7 days, fever gets worse or lasts >3 days; nervousness, dizziness or sleeplessness occurs, or if cough comes back or occurs with rash or headache that lasts; further evaluate the patients as these could be signs of a serious condition
• 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
• Therapy may cause excitability, particularly in children
• Marked drowsiness or blurred vision may occur with this drug; concomitant use of other sedatives and tranquilizers may worsen these effects. Hence, avoid use of these drugs and advise patients to avoid alcohol during therapy

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Asthma
• Chronic cough
• Cough with excessive phlegm
• Angle-closure glaucoma
• Anticoagulant use
• Chronic alcohol use
• Severe hypovolemia
• Chronic malnutrition
• PKU (phenylalanine-containing forms)

Supplemental Patient Information

• Advise patients to avoid driving a motor vehicle or operating machinery, as marked drowsiness may occur with this product
• Advise patients to consult their physician if symptoms do not improve in 7 days, if new symptoms occur, or if fever gets worse or lasts more than 3 days
• Instruct patients to avoid alcoholic beverages during therapy

Pregnancy Category:B (acetaminophen), C (dextromethorphan)

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 22 June 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 22 June 2011).No studies conducted on the excretion of dextromethorphan in milk or its effect on breastfed infants. However, this medication can be administered to infants as young as 1 month of age. It is unlikely that with usual maternal doses amounts in milk are as large as those given directly to infants or that breastfed infants would be harmed by the drug in breastmilk, especially in infants over 1 month of age. Avoid the use of products with high alcohol content while nursing. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 June 2011). Manufacturer advises to consult a health professional.

• GI: Hepatotoxicity, nausea, abdominal pain
• CNS: Dizziness, headache, serotonin syndrome, abuse potential, drowsiness, fatigue
• GU: Acute renal tubular necrosis, chronic analgesic nephropathy
• HEMA: Anemia, thrombocytopenia
• DERM: Rash
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions

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: CYP2E1, CYP1A2
• Excreted in urine 85% (5-10% unchanged)
• Half-life: 1.25-3 hrs

Dextromethorphan

• Non-narcotic antitussive; suppresses cough by directly acting on cough center in the medulla
• Rapid absorption
• Metabolized by liver; CYP450: 2D6 substrate
• Excreted in urine
• Half-life: 11 hrs

US Trade Name(s)

• Children's Tylenol Plus Cough & Sore Throat
• Children's Triaminic Cough & Sore Throat
• PediaCare Children's Fever Reducer Plus Cough & Sore Throat
• Tylenol Cough & Sore Throat Daytime

US Availability

Children's Tylenol Plus Cough & Sore Throat (acetaminophen/dextromethorphan)

• SUSP: [160 mg/5 mg]/5 mL

Children's Triaminic Cough & Sore Throat (acetaminophen/dextromethorphan)

• SOLN: [160 mg/5 mg]/5 mL
• TABS: 160 mg/5 mg

PediaCare Children's Fever Reducer Plus Cough & Sore Throat (acetaminophen/dextromethorphan)

• SUSP: [160 mg/5 mg]/5 mL

Tylenol Cough & Sore Throat Daytime (acetaminophen/dextromethorphan)

• SOLN: [1000 mg/30 mg]/30 mL

Canadian Trade Name(s)

• Extra Strength Tylenol Cough Caplets
• Triaminic Cough and Sore Throat Softchews
• Triaminic Fever & Cough
• Tylenol Cough

Canadian Availability

Extra Strength Tylenol Cough Caplets (acetaminophen/dextromethorphan)

• TABS: 500 mg/15 mg

Triaminic Cough and Sore Throat Softchews (acetaminophen/dextromethorphan)

• CHEW TABS: 160 mg/5 mg

Triaminic Fever & Cough (acetaminophen/dextromethorphan)

• LIQ: [160 mg/5 mg]/5 mL

Tylenol Cough (acetaminophen/dextromethorphan)

• LIQ: [1000 mg/30mg]/30 mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations