Adult Dosing

Temporary relief of symptoms associated with cold and flu, hay fever, or other respiratory allergies

• Alka-Seltzer Plus Cold & Cough, Tylenol Cold Multi-Symptom Nighttime Gels, Tylenol Cold Head Congestion Nighttime, Theraflu Nighttime Severe Cold & Cough Caplets
• 2 TABS/CAPS (acetaminophen 650 mg/chlorpheniramine 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) with water PO q4 hrs PRN
• Max: 12 TABS or CAPS/day

• Alka-Seltzer Plus Flu
• 2 TABS (acetaminophen 500 mg/chlorpheniramine 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) dissolved in 4 oz of water q4 hrs PRN
• Max: 8 TABS/day

• Robitussin Night Time Cough, Cold & Flu
• 20 mL PO q4 hrs PRN; Max: 100 mL/day

• Children's Dimetapp Multi-Symptom Cold & Flu
• 20 mL PO q4 hrs PRN; Max: 100 mL/day

Pediatric Dosing

Temporary relief of symptoms associated with cold and flu, hay fever, or other respiratory allergies

• Children's Tylenol Plus Flu, Children's Tylenol Plus Multi-Symptom Cold, PediaCare Children's Fever Reducer Plus Flu, PediaCare Children's Fever Reducer Plus Multi-Symptom 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

• Children's Dimetapp Multi-Symptom Cold & Flu
• Children <6 yrs: Do not use
• Children 6-11 yrs: 10 mL PO q4 hrs PRN; Max: 50 mL/day
• Children >12 yrs: 20 mL PO q4 hrs PRN; Max: 100 mL/day

• Robitussin Night Time Cough, Cold & Flu (children >12 yrs)
• 20 mL PO q4 hrs PRN; Max: 100 mL/day

• Alka-Seltzer Plus Cold & Cough, Tylenol Cold Multi-Symptom Nighttime Gels, Tylenol Cold Head Congestion Nighttime (Children >12 yrs)
• 2 TABS/CAPS (acetaminophen 650 mg/chlorpheniramine 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) PO q4 hrs PRN
• Max: 12 TABS or CAPS/day

• Theraflu Nighttime Severe Cold & Cough Caplets
• Children <4 yrs: Do not use
• Children 4-11 yrs: Consult a physician before use
• Children >12 yrs: 2 TABS (acetaminophen 650 mg/chlorpheniramine 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) PO q4 hrs PRN; Max: 12 TABS/day

• Alka-Seltzer Plus Flu (Children >12 yrs)
• 2 TABS (acetaminophen 500 mg/chlorpheniramine 4 mg/dextromethorphan 20 mg/phenylephrine 10 mg) dissolved in 4 oz of water q4 hrs PRN
• Max: 8 TABS/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of symptoms associated with common cold and flu, hay fever, or other respiratory allergies including
• Minor aches and pains
• Cough due to minor throat and bronchial irritation
• Headache
• Sore throat
• Sneezing and runny nose
• Stuffy nose
• Nasal and sinus congestion
• Itchy, watery eyes
• Itching of the nose or throat

• 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
• Uncontrolled or 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

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

Hepatic Dose Adjustment

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

• chlorpheniramine/dextromethorphan/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
• Antihistamine produces paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs
• 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 5 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
• Avoid use of this combination therapy to sedate children

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Asthma
• COPD
• Chronic cough as occurs with smoking, chronic bronchitis, or emphysema
• Lower respiratory tract symptoms
• Increased IOP
• Angle-closure glaucoma
• Cardiovascular disease
• Hypertension
• Arrhythmias
• Diabetes mellitus
• CNS depressant use
• Chronic alcohol use
• Cough with too much phlegm
• Anticoagulant use
• PUD
• Prostatic hypertrophy
• Bladder neck obstruction
• Hyperthyroidism
• Severe hypovolemia
• Chronic malnutrition
• Sodium-restricted diet
• 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 (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. 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. 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. 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).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). Manufacturer advises to consult a health professional.

• CNS: Drowsiness, dizziness, paradoxical CNS stimulation (in children), incoordination, headache, seizures, restlessness, CNS stimulation, nervousness, weakness, tremors, serotonin syndrome
• PSYCHIATRY: Toxic psychosis, abuse potential, anxiety, insomnia
• CV: Hypertension, arrhythmias, hypotension, palpitations, tachycardia, reflex bradycardia
• RESP: Thickening of bronchial secretions
• GI: Hepatotoxicity, epigastric discomfort, dry mouth, constipation, nausea, abdominal pain
• 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, fatigue

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

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 Cold & Cough
• Alka-Seltzer Plus Flu
• Children's Dimetapp Multi-Symptom Cold & Flu
• Children's Tylenol Plus Flu
• Children's Tylenol Plus Multi-Symptom Cold
• PediaCare Children's Fever Reducer Plus Flu
• PediaCare Children's Fever Reducer Plus Multi-Symptom Cold
• Robitussin Night Time Cough
• Cold & Flu
• Tylenol Cold Multi-Symptom Nighttime Gels
• Tylenol Cold Head Congestion Nighttime
• Theraflu Nighttime Severe Cold & Cough Caplets

US Availability

Alka-Seltzer Plus Cold & Cough, Tylenol Cold Multi-Symptom Nighttime Gels (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• CAPS: 325 mg/2 mg/10 mg/5 mg

Tylenol Cold Head Congestion Nighttime, Theraflu Nighttime Severe Cold & Cough Caplets (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• TABS: 325 mg/2 mg/10 mg/5 mg

Alka-Seltzer Plus Flu (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• TABS: 250 mg/2 mg/10 mg/5 mg

Children's Tylenol Plus Flu, Children's Dimetapp Multi-Symptom Cold & Flu (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• LIQ: [160 mg/1 mg/5 mg/2.5 mg]/5 mL

Robitussin Night Time Cough, Cold & Flu (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• SOLN: [160 mg/1 mg/5 mg/2.5 mg]/5 mL

Children's Tylenol Plus Multi-Symptom Cold, PediaCare Children's Fever Reducer Plus Flu, PediaCare Children's Fever Reducer Plus Multi-Symptom Cold (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• SUSP: [160 mg/1 mg/5 mg/2.5 mg]/5 mL

Canadian Trade Name(s)

• Extra Strength Nighttime Cold Relief PE
• Extra Strength Nighttime Flu PE
• Extra Strength Tylenol Cold Nighttime
• Extra Strength Tylenol Flu Nighttime
• Nighttime Extra Strength Contac Complete Cough
• Cold & Flu; Regular Strength Tylenol Cold Nighttime
• Tylenol Cold Nighttime Rapid Release

Canadian Availability

Extra Strength Nighttime Cold Relief PE, Extra Strength Nighttime Flu PE, Extra Strength Tylenol Cold Nighttime, Extra Strength Tylenol Flu Nighttime (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• OTC TABS: 500 mg/2 mg/10 mg/5 mg

Nighttime Extra Strength Contac Complete Cough, Cold & Flu (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• OTC TABS: 500 mg/2 mg/15 mg/5 mg

Regular Strength Tylenol Cold Nighttime, Tylenol Cold Nighttime Rapid Release (acetaminophen/chlorpheniramine/dextromethorphan/phenylephrine)

• OTC TABS: 325 mg/2 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]

Allergy/Cold

Cough/Cold Non-Narcotic Combinations

ENT

Cough/Cold Non-Narcotic Combinations