Adult Dosing

Cold/flu/hay fever or other upper respiratory allergies

• Alka-Seltzer Plus Cold Formula Fast Powder Packs
• 1 packet PO q4 hrs PRN; Max: 5 packets/day
• Dissolve 1 powder packet in 6-8 ounces of hot or cold beverage (juice, tea, black coffee, or water) and consume entire beverage within 15 minutes

• Dristan Cold, Robitussin Peak Cold Nighttime Nasal Relief, Tylenol Sinus Congestion & Pain Nighttime
• 2 tabs (acetaminophen 325 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4 hrs PRN; Max: 12 tabs/day

• Tylenol Allergy Multi-Symptom
• 2 tabs/caps (acetaminophen 325 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4 hrs PRN; Max: 12 tabs or caps/day

• Sine-Off Sinus/Cold, Contac Cold And Flu Maximum Strength
• 2 tabs (acetaminophen 500 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4-6 hrs PRN; Max: 8 tabs/day

Pediatric Dosing

Cold/flu/hay fever or other upper respiratory allergies

• Alka-Seltzer Plus Cold Fast Crystal Packs (>12 yrs)
• 1 packet PO q4 hrs PRN; Max: 5 packets/day
• Dissolve 1 powder packet in 6-8 ounces of hot or cold beverage (juice, tea, black coffee, or water) and consume entire beverage within 15 minutes

• Dristan Cold, Robitussin Peak Cold Nighttime Nasal Relief, Tylenol Sinus Congestion & Pain Nighttime (>12 yrs)
• 2 tabs (acetaminophen 325 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4 hrs PRN; Max: 12 tabs/day

• Tylenol Allergy Multi-Symptom (>12 yrs)
• 2 tabs/caps (acetaminophen 325 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4 hrs PRN; Max: 12 tabs or caps/day

• Sine-Off Sinus/Cold, Contac Cold And Flu Maximum Strength (>12 yrs)
• 2 tabs (acetaminophen 500 mg/chlorpheniramine 2 mg/phenylephrine 5 mg) PO q4-6 hrs PRN; Max: 8 tabs/day

• Children's Tylenol Plus Cold
• Children <4 yrs or <36 lbs: Do not use
• Children 4-5 yrs or 36-47 lbs: Consult a physician before use
• Children 6-11 yrs or 48-95 lbs: 10 mL PO q4 hrs PRN; Max: 50 mL/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of cold/flu symptoms including minor aches and pains, headache, runny nose, sneezing, sore throat, sinus and nasal congestion
• Temporarily relieves symptoms of hay fever or other upper respiratory allergies including headache, sneezing, runny nose, itchy/watery eyes, itching of the nose or throat, sinus congestion and pressure, and nasal congestion
• 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
• Co-administration with other drugs containing acetaminophen
• Severe hypertension
• Coronary artery disease
• Urinary retention
• To sedate a child

• N/A

Renal Dose Adjustment (Based on CrCl)

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

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

Hepatic Dose Adjustment

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

• chlorpheniramine/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 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
• 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
• Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs
• Avoid use of this combination therapy to sedate children

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• History of asthma
• COPD
• Lower respiratory tract symptoms
• Increased IOP
• Angle-closure glaucoma
• Cardiovascular disease
• Hypertension
• Arrhythmias
• Diabetes mellitus
• CNS depressant use
• Chronic alcohol use
• Anticoagulant use
• PUD
• Prostatic hypertrophy
• Bladder neck obstruction
• Hyperthyroidism
• Severe hypovolemia
• Chronic malnutrition
• Poor CYP2D6 metabolizer
• PKU (phenylalanine-containing forms)
• GI obstruction
• Geriatric population
• High environmental temperature

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), B (chlorpheniramine), 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. Chlorpheniramine: Small, occasional doses of chlorpheniramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause adverse effects in the infant or interfere with lactation, particularly in combination with a sympathomimetic agent or when lactation is not well established. However, the nonsedating antihistamines are preferred alternatives. Phenylephrine: 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. Acetaminophen: 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://pediatrics.aappublications.org/content/108/3/776/T6.full last accessed 10 May 2011)

• CNS: Drowsiness, dizziness, paradoxical CNS stimulation (in children), incoordination, headache, seizures, toxic psychosis, anxiety, nervousness, weakness, tremors, insomnia
• CV: Hypertension, arrhythmias, hypotension, palpitations, tachycardia
• RESP: Thickening of bronchial secretions, chest tightness
• GI: Hepatotoxicity, epigastric discomfort, constipation, nausea
• EENT: Blurred vision, diplopia, acute labyrinthitis
• HEMA: Hemolytic anemia, anemia, thrombocytopenia, agranulocytosis, pancytopenia, leukopenia
• GU: Urinary retention, dysuria, erectile dysfunction, acute renal tubular necrosis, chronic analgesic nephropathy
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, photosensitivity, rash
• MISC: Dry mucous membranes, diaphoresis, heat stroke

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

Chlorpheniramine

• I generation antihistamine; competitively antagonizes central and peripheral H1 receptors (non-selective antihistamine); suppresses the medullary cough center (antitussive); exhibits antidyskinetic, antiemetic and sedative effects due to its anticholinergic properties
• Well absorbed following oral administration
• Metabolized by GI tract, liver; CYP450: 2D6, 3A4 substrate
• Renally excreted (minimally unchanged)
• Half-life: 21-27 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 Cold Formula Fast Powder Packs
• Children's Tylenol Plus Cold
• Contac Cold And Flu Maximum Strength
• Dristan Cold
• Robitussin Peak Cold Nighttime Nasal Relief
• Sine-Off Sinus/Cold
• Tylenol Allergy Multi-Symptom
• Tylenol Sinus Congestion & Pain Nighttime

US Availability

Alka-Seltzer Plus Cold Formula Fast Powder Packs (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 650 mg/4 mg/10 mg

Children's Tylenol Plus Cold (acetaminophen/chlorpheniramine/phenylephrine)

• LIQ: [160 mg/1 mg/2.5 mg]/5 mL

Contac Cold And Flu Maximum Strength

• TABS: 500 mg/2 mg/5 mg

Dristan Cold, Robitussin Peak Cold Nighttime Nasal Relief, Tylenol Sinus Congestion & Pain Nighttime (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 325 mg/2 mg/5 mg

Tylenol Allergy Multi-Symptom

• TABS: 325 mg/2 mg/5 mg
• CAPS: 325 mg/2 mg/5 mg

Sine-Off Sinus/Cold (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 500 mg/2 mg/5 mg

Canadian Trade Name(s)

• Benylin Cold & Sinus Plus
• Benylin Cold & Sinus Night
• Children's Coltalin Fruit Flavor Chewable Cold Tablets
• Coltalin Cold & Allergy Tablets
• Dristan
• Dimetapp Nighttime Cold Extra Strength Caplets
• Dristan Extra Strength Caplets
• Extra Strength Tylenol Allergy
• Extra Strength Tylenol Sinus Nighttime
• Nighttime Extra Strength Contact Cold & Sore Throat

Canadian Availability

Benylin Cold & Sinus Plus, Benylin Cold & Sinus Night, Dimetapp Nighttime Cold Extra Strength Caplets, Dristan Extra Strength Caplets, Extra Strength Tylenol Allergy, Extra Strength Tylenol Sinus Nighttime, Nighttime Extra Strength Contact Cold & Sore Throat (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 500 mg/2 mg/5 mg

Children's Coltalin Fruit Flavor Chewable Cold Tablets (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 80 mg/0.5 mg/1.25 mg

Coltalin Cold & Allergy Tablets, Dristan (acetaminophen/chlorpheniramine/phenylephrine)

• TABS: 325 mg/2 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