Adult Dosing

Symptoms associated with cold and flu, hay fever, minor throat/bronchial irritation or other respiratory allergies

• Alka-Seltzer Plus Day Cold, Alka-Seltzer Plus Day Non-Drowsy Cold and Flu, Alka-Seltzer Plus Day Severe Sinus Congestion & Cough, Theraflu Warming Relief Daytime Multi-Symptom Cold, Tylenol Cold Head Congestion Daytime
• 2 CAPS/TABS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps or TABS/day

• Theraflu Daytime Severe Cold & Cough
• 2 TABS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 TABS/day
• Alt: 1 packet PO q4 hrs PRN; Max: 6 packets/day

• Theraflu Warming Relief Daytime Severe Cold & Cough
• 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Tylenol Cold Multi-Symptom Daytime
• 2 CAPS/TABS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps or TABS/day
• Alt: 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Vicks DayQuil Cold & Flu Multi-Symptom Relief
• 2 CAPS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps/day
• Alt: 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Alka-Seltzer Plus Day Severe Cold, cough and Flu
• 1 packet PO q4hrs PRN. Max: 5 packets/24 hr

Pediatric Dosing

Symptoms associated with cold and flu, hay fever, minor throat/bronchial irritation or other respiratory allergies

• Alka-Seltzer Plus Day Cold, Alka-Seltzer Plus Day Non-Drowsy Cold and Flu, Theraflu Warming Relief Daytime Multi-Symptom Cold, Tylenol Cold Head Congestion Daytime (>12 yrs)
• 2 CAPS/TABS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps or TABS/day

• Children's Tylenol Plus Cold & Cough
• Children 4-5 yrs or 36-47 lb: 5 mL PO q4 hrs PRN; Max: 25 mL/day
• Children 6-11 yrs or 48-95 lb: 10 mL PO q4 hrs PRN; Max: 50 mL/day

• Little Colds Multi-Symptom Cold Formula
• Children 4-6 yrs: 2 mL q4 hrs PRN; Max: 10 mL/day
• Children 6-12 yrs: 4 mL q4 hrs PRN; Max: 20 mL/day

• Theraflu Warming Relief Daytime Severe Cold & Cough (>12 yrs)
• 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Theraflu Daytime Severe Cold & Cough (>12 yrs)
• 2 TABS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 TABS/day
• Alt: 1 packet PO q4 hrs PRN; Max: 6 packets/day

• Tylenol Cold Multi-Symptom Daytime (>12 yrs)
• 2 CAPS/TABS(acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps or TABS/day
• Alt: 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Vicks DayQuil Cold & Flu Multi-Symptom Relief (>12 yrs)
• 2 CAPS (acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg) PO q4 hrs PRN
• Max: 12 Caps/day
• Alt: 30 mL PO q4 hrs PRN; Max: 180 mL/day

• Alka-Seltzer Plus Day Severe Cold, cough and Flu
• 1 packet PO q4hrs PRN. Max: 5 packets/24 hr

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of symptoms associated with common cold and flu, hay fever, minor throat/bronchial irritation or other respiratory allergies including minor aches and pains, headache, cough, sore throat, nasal and sinus congestion
• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Concomitant use with other drugs containing acetaminophen, decongestants or cough suppressants
• Concomitant use of monoamine oxidase inhibitor (MAOI) or within 2 wks of stopping MAOI
• Severe hypertension
• Coronary artery disease
• Urinary retention

• N/A

Renal Dose Adjustment (Based on CrCl)

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

• Dextromethorphan/phenylephrine
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

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

• Dextromethorphan/phenylephrine
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Over-dosage of this product may cause severe liver damage; severe liver damage 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
• 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
• 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
• Dizziness, drowsiness, or blurred vision may occur with this drug; concomitant use of other sedatives and tranquilizers and alcohol abuse 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
• Cardiac disease
• Arrhythmias
• Chronic alcohol use
• Angle-closure glaucoma
• Severe hypovolemia
• Chronic malnutrition
• PKU (phenylalanine-containing forms)
• Hypertension
• Hyperthyroidism
• Diabetes mellitus
• Cough with excessive phlegm
• Prostatic hypertrophy
• CNS depressant use
• Anticoagulant use

Supplemental Patient Information

• Advise patients to avoid driving a motor vehicle or operating machinery, as 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), C (phenylephrine)

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 10 May 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 10 May 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 a 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 10 May 2011).Phenylephrine is unlikely to reach the infant in large amounts, as the oral bioavailability of phenylephrine is only about 40%. However, oral administration of phenylephrine decreases milk production. As no information is available on the use of oral phenylephrine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 May 2011). Manufacturer advises to consult a health professional.

• GI: Hepatotoxicity, nausea, abdominal pain
• CV: Hypertension, palpitations, arrhythmias, tachycardia
• CNS: Restlessness, anxiety, nervousness, weakness, dizziness, tremor, insomnia, headache, serotonin syndrome, abuse potential, drowsiness, fatigue, CNS stimulation
• GU: Acute renal tubular necrosis, chronic analgesic nephropathy, urinary retention
• RESP: Respiratory distress
• 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

Phenylephrine

• Nasal decongestant; stimulates alpha1-adrenergic receptors in the arterioles of the nasal mucosa, producing vasoconstriction and reducing nasal congestion
• Metabolized in intestinal wall and liver
• Renally excreted 80% (2.6% unchanged)
• Half-life: 2-3 hrs

US Trade Name(s)

• Alka-Seltzer Plus Day Cold
• Alka-Seltzer Plus Day Non-Drowsy Cold and Flu
• Alka-Seltzer Plus Day Severe Cold
• cough and Flu
• Alka-Seltzer Plus Day Severe Sinus Congestion & Cough
• Children's Tylenol Plus Cold & Cough
• Little Colds Multi-Symptom Cold Formula
• Theraflu Daytime Severe Cold & Cough
• Theraflu Warming Relief Daytime Multi-Symptom Cold
• Theraflu Warming Relief Daytime Severe Cold & Cough
• Tylenol Cold Head Congestion Daytime
• Tylenol Cold Multi-Symptom Daytime
• Vicks DayQuil Cold & Flu Multi-Symptom Relief

US Availability

Alka-Seltzer Plus Day Cold, Alka-Seltzer Plus Day Non-Drowsy Cold and Flu, Alka-Seltzer Plus Day Severe Sinus Congestion & Cough, (acetaminophen/dextromethorphan/phenylephrine)

• CAPS: 325 mg/10 mg/5 mg

Alka-Seltzer Plus Day Severe Cold, Cough & Flu (acetaminophen/dextromethorphan/phenylephrine)

• OTC ORAL PWDR: [650 mg/20 mg/10 mg]/packet

Children's Tylenol Plus Cold & Cough

• LIQ: [160 mg/5 mg/2.5 mg]/5 mL

Little Colds Multi-Symptom Cold Formula

• SOLN: [80 mg/2.5 mg/1.25 mg]/mL

Theraflu Daytime Severe Cold & Cough

• PWDR: [650 mg/20 mg/10 mg]/packet
• TABS: 325 mg/10 mg/5 mg

Theraflu Warming Relief Daytime Severe Cold & Cough

• SYRUP: [325 mg/10 mg/5 mg]/15 mL

Tylenol Cold Head Congestion Daytime, Theraflu Warming Relief Daytime Multi-Symptom Cold

• TABS: 325 mg/10 mg/5 mg

Tylenol Cold Multi-Symptom Daytime

• CAPS: 325 mg/10 mg/5 mg
• LIQ: [325 mg/10 mg/5 mg]/15 mL

Vicks DayQuil Cold & Flu Multi-Symptom Relief

• CAPS: 325 mg/10 mg/5 mg
• LIQ: [325 mg/10 mg/5 mg]/15 mL

Canadian Trade Name(s)

• DayQuil Cold & Flu
• Daytime Cold/Flu
• Extra Strength Contac Complete Cough
• Cold & Flu
• Extra Strength Daytime Cold Relief PE
• Extra Strength Daytime Flu PE
• Extra Strength Neocitran Total Day
• Extra Strength Neocitran Total Syrup
• Extra Strength Tylenol Cold Daytime
• Extra Strength Tylenol Flu Daytime
• Little Colds Multi-Symptom Cold Formula
• Regular Strength Tylenol Cold Daytime
• Tylenol Cold and Flu Daytime
• Tylenol Cold Rapid Release
• Vicks DayQuil Cold & Flu Multi-Symptom Relief

Canadian Availability

DayQuil Cold & Flu, Daytime Cold/Flu, Tylenol Cold and Flu Daytime (acetaminophen/dextromethorphan/phenylephrine)

• LIQ: [650 mg/20 mg/10 mg]/30 mL

Extra Strength Contac Complete Cough, Cold & Flu

• TABS: 500 mg/15 mg/5 mg

Extra Strength Daytime Cold Relief PE, Extra Strength Daytime Flu PE, Extra Strength Tylenol Cold Daytime, Extra Strength Tylenol Flu Daytime

• TABS: 500 mg/10 mg/5 mg

Extra Strength Neocitran Total Day

• PWDR: [650 mg/20 mg/10 mg]/packet

Extra Strength Neocitran Total Syrup

• SYRUP: [650 mg/20 mg/10 mg]/30 mL

Little Colds Multi-Symptom Cold Formula

• LIQ: [80 mg/2.5 mg/1.25 mg]/mL

Regular Strength Tylenol Cold Daytime, Tylenol Cold Rapid Release

• TABS: 325 mg/10 mg/5 mg

Vicks DayQuil Cold & Flu Multi-Symptom Relief

• CAPS: 325 mg/10 mg/5 mg

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