Adult Dosing

Relief of symptoms associated with cold and flu, hay fever, or other upper respiratory allergies

Excedrin Sinus Headache, Robitussin Peak Cold Nasal Relief, Sudafed PE Pressure + Pain

• 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Sine-Off Maximum Strength, Contac Cold + Flu Non-Drowsy

• 1000 mg/10 mg PO q4-6hrs PRN
• Max: [4000 mg/40 mg]/day

Tylenol Sinus Congestion & Pain Daytime

• 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Vicks DayQuil Sinex Daytime Sinus Relief

• 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Note:

• Swallow whole; do not crush, chew or dissolve

Pediatric Dosing

Relief of symptoms associated with cold and flu, hay fever, or other upper respiratory allergies

Children's Tylenol Plus Cold & Stuffy Nose

• <36 lbs or <4 yrs: Avoid use
• 36-47 lbs or 4-5 yrs: 5 mL PO q4hrs PRN. Max: 75 mg/kg/day acetaminophen; 15 mg/day phenylephrine
• 48-95 lbs or 6-11 yrs: 10 mL PO q4hrs PRN. Max: 75 mg/kg/day acetaminophen; 30 mg/day phenylephrine

• Use enclosed dosing cup specifically designed for use with this product; avoid using other dosing devices

Excedrin Sinus Headache

• <12 yrs: Consult doctor before use
• >12 yrs: 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Robitussin Peak Cold Nasal Relief, Sudafed PE Pressure + Pain

• <12 yrs: Avoid use
• >12 yrs: 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Sine-Off Maximum Strength, Contac Cold + Flu Non-Drowsy

• <12 yrs: Avoid use
• >12 yrs: 1000 mg/10 mg PO q4-6hrs PRN
• Max: [4000 mg/40 mg]/day

Tylenol Sinus Congestion & Pain Daytime

• <12 yrs: Avoid use
• >12 yrs: 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Vicks DayQuil Sinex Daytime Sinus Relief

• <4 yrs: Avoid use
• 4-11 yrs: Consult doctor before use
• 12 yrs: 650 mg/10 mg PO q4hrs PRN
• Max: [3900 mg/60 mg]/day

Note:

• Swallow whole; do not crush, chew or dissolve

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of symptoms associated with cold and flu, hay fever or other upper respiratory allergies
• Headache
• Sore throat
• Sneezing and runny nose
• Stuffy nose
• Minor aches and pains
• Nasal congestion
• Sinus congestion and pressure
• Helps decongest sinus openings and passages
• Promotes sinus drainage
• Restores freer breathing through the nose
• Reduces swelling of nasal passages

• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of monoamine oxidase inhibitor or use within 14 days of stopping MAOI therapy
• Co-administration with other drugs containing acetaminophen
• Coronary artery disease
• Uncontrolled or severe hypertension
• Urinary retention

• N/A

Renal Dose Adjustment (Based on CrCl)

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

• Phenylephrine
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

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

• Phenylephrine
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• 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
• 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
• Dizziness, drowsiness, or blurred vision may occur with this drug; concomitant use with other sedatives, tranquilizers, and alcohol may worsen these effects. Hence, avoid use of these drugs and advise patients to avoid alcohol during therapy
• Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is noted, pain/nasal congestion gets worse or lasts more than 7 days, fever gets worse or lasts >3 days, or if nervousness, dizziness or sleeplessness occurs; further evaluate the patients as these could be signs of a serious condition

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Arrhythmias
• Cardiovascular disease
• Chronic alcohol use
• Diabetes mellitus
• Angle-closure glaucoma
• Hypertension
• Hyperthyroidism
• Severe hypovolemia
• Chronic malnutrition
• Anticoagulant use
• PKU (phenylalanine-containing forms)
• Prostatic hypertrophy
• Geriatric population

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 (phenylephrine)

Breastfeeding: Acetaminophen component of this combination drug 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. 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 12 July 2011). Maternal medication of acetaminophen 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 12 July 2011). Manufacturer advises to consult a health professional.

• CV: Hypertension, arrhythmias, palpitations, tachycardia, elevated BP
• CNS: Headache, CNS stimulation, dizziness, insomnia, tremor
• PSYCHIATRY: Anxiety
• GI: Nausea, vomiting
• GU: Urinary retention, chronic analgesic nephropathy, acute renal tubular necrosis
• HEMA: Anemia, thrombocytopenia
• DERM: Rash
• HEPA: Hepatotoxicity
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions
• MISC: Fever

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

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)

• Children's Tylenol Plus Cold & Stuffy Nose
• Contac Cold + Flu Non-Drowsy
• Excedrin Sinus Headache
• Robitussin Peak Cold Nasal Relief
• Sine-Off Maximum Strength
• Sudafed PE Pressure + Pain
• Tylenol Sinus Congestion & Pain Daytime
• Vicks DayQuil Sinex Daytime Sinus Relief

US Availability

Children's Tylenol Plus Cold & Stuffy Nose (acetaminophen/phenylephrine)

• SUSP: [160 mg/2.5 mg]/5 mL

Excedrin Sinus Headache, Robitussin Peak Cold Nasal Relief, Sudafed PE Pressure + Pain (acetaminophen/phenylephrine)

• TABS: 325 mg/5 mg

Sine-Off Maximum Strength, Contac Cold + Flu Non-Drowsy (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

Tylenol Sinus Congestion & Pain Daytime (acetaminophen/phenylephrine)

• TABS: 325 mg/5 mg
• CAPS: 325 mg/5 mg

Vicks DayQuil Sinex Daytime Sinus Relief (acetaminophen/phenylephrine)

• CAPS: 325 mg/5 mg

Canadian Trade Name(s)

• Benylin Cold & Sinus
• DayQuil Sinus Liquicaps
• Dilotab II
• Extra Strength Contac Cold & Sore Throat
• Extra Strength Tylenol Sinus Daytime
• Extra Strength NeoCitran Cold Day
• Regular Strength Tylenol Sinus Daytime

Canadian Availability

Benylin Cold & Sinus (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

DayQuil Sinus Liquicaps (acetaminophen/phenylephrine)

• CAPS: 325 mg/5 mg

Extra Strength Contac Cold & Sore Throat (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

Extra Strength Tylenol Sinus Daytime (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

Extra Strength NeoCitran Cold Day (acetaminophen/phenylephrine)

• PWDR for SOLN: [650 mg/10 mg]/pack

Dilotab II, Regular Strength Tylenol Sinus Daytime (acetaminophen/phenylephrine)

• TABS: 325 mg/5 mg

UK Trade Name(s)

• Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour Powder for Oral Solution
• Boots Cold & Flu Max Relief Sachets Blackcurrant Flavour
• Boots Cold and Flu Max Relief Sachets Lemon Flavour
• Boots Cold and Flu Relief with Decongestant Powder
• Boots Cold and Flu Max Direct Sachets Blackcurrant Flavour
• Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon
• Lemsip Cold & Flu Blackcurrant
• Lemsip Cold & Flu Breathe Easy
• Lemsip Cold & Flu Lemon
• Lemsip Max Cold & Flu Breathe Easy
• Lemsip Max Cold and Flu Blackcurrant
• Lemsip Max Cold and Flu Direct Lemon
• Lemsip Max Cold & Flu Lemon
• Lemsip Max Lemon Flavour Tablets
• Lemsip Max Sinus
• Lemsip Max Blackcurrant Flavour Tablets

UK Availability

Beechams Breathe Clear Hot Honey & Lemon Menthol Flavour Powder for Oral Solution (acetaminophen/phenylephrine)

• PWDR for SOLN: 600 mg/10 mg

Boots Cold & Flu Max Relief Sachets Blackcurrant Flavour (acetaminophen/phenylephrine)

• PWDR for SOLN: 1000 mg/12.2 mg

Boots Cold and Flu Max Relief Sachets Lemon Flavour (acetaminophen/phenylephrine)

• PWDR for SUSP: 1000 mg/12.2 mg

Boots Cold and Flu Max Direct Sachets Blackcurrant Flavour, Boots Maximum Strength Cold & Flu Relief Direct Dose Lemon, Lemsip Max Cold & Flu Breathe Easy, Lemsip Max Cold and Flu Blackcurrant, Lemsip Max Cold and Flu Direct Lemon, Lemsip Max Cold & Flu Lemon, Lemsip Max Sinus (acetaminophen/phenylephrine)

• PWDR: 1000 mg/12.2 mg

Boots Cold and Flu Relief with Decongestant Powder, Lemsip Cold & Flu Blackcurrant, Lemsip Cold & Flu Breathe Easy (acetaminophen/phenylephrine)

• PWDR for SOLN: 650 mg/10 mg

Lemsip Cold & Flu Lemon (acetaminophen/phenylephrine)

• PWDR: 650 mg/10 mg

Lemsip Max Lemon Flavour Tablets (acetaminophen/phenylephrine)

• TABS: 500 mg/6.10 mg

Lemsip Max Blackcurrant Flavour Tablets (acetaminophen/phenylephrine)

• TABS: 500 mg/6.10 mg

Australian Trade Name(s)

• Dimetapp PE Sinus Pain
• Nyal Nasal Decongestant + Pain Relief PE
• Nyal Sinus + Pain Relief PE
• Panadol Cold & Flu + Decongestant
• Panadol Cold & Flu Max + Decongestant Hot Lemon
• Panadol Sinus Relief PE
• Sudafed PE Sinus + Pain Relief

Australian Availability

Dimetapp PE Sinus Pain, Nyal Nasal Decongestant + Pain Relief PE, Nyal Sinus + Pain Relief PE, Panadol Cold & Flu + Decongestant, Panadol Sinus Relief PE (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

Panadol Cold & Flu Max + Decongestant Hot Lemon (acetaminophen/phenylephrine)

• PWDR: 1000 mg/10 mg

Sudafed PE Sinus + Pain Relief (acetaminophen/phenylephrine)

• TABS: 500 mg/5 mg

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations