Adult Dosing

Cold/fever/hay fever or other upper respiratory allergies

• Theraflu Cold & Sore Throat
• 1 packet [325 mg/20 mg/10 mg] PO q4 hrs; Max: 6 packets/day
• Dissolve contents of one packet in 8 oz. hot water or add contents to 8 oz. cool water and microwave
• Sip while the solution is hot and consume entire drink within 10-15 minutes

• Theraflu Flu & Sore Throat
• 1 packet [650 mg/20 mg/10 mg] PO q4 hrs; Max: 6 packets/day
• Dissolve contents in 8 oz. hot water or add contents to 8 oz. cool water and microwave
• Sip while the solution is hot and consume entire drink within 10-15 minutes

Note:

• Do not overheat the solution

Pediatric Dosing

Cold/fever/hay fever or other upper respiratory allergies

Theraflu Cold & Sore Throat

• Children <4 yrs
• Safety and effectiveness in pediatric patients <4 yrs have not been established

• Children 4-12 yrs
• Do not use unless recommended by a physician

• Children 12 yrs
• 1 packet [325 mg/20 mg/10 mg] PO q4 hrs; Max: 6 packets/day
• Dissolve contents of one packet in 8 oz. hot water or add contents to 8 oz. cool water and microwave
• Sip while the solution is hot and consume entire drink within 10-15 minutes

Theraflu Flu & Sore Throat

• Children <4 yrs
• Safety and effectiveness in pediatric patients <4 yrs have not been established

• Children 4-12 yrs
• Do not use unless recommended by a physician

• Children >12 yrs
• 1 packet [650 mg/20 mg/10 mg] PO q4 hrs; Max: 6 packets/day
• Dissolve contents in 8 oz. hot water or add contents to 8 oz. cool water and microwave
• Sip while the solution is hot and consume entire drink within 10-15 minutes

Note:

• Do not overheat the solution

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporarily reduces fever
• Temporary relief from cold symptoms including
• Minor aches and pains
• Headache
• Sore throat pain
• Nasal congestion

• Temporary relief from symptoms of hay fever or other upper respiratory allergies such as
• Runny nose
• Sneezing
• Itchy throat and nose
• Itchy and watery eyes

• 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
• Coronary artery disease
• Severe or uncontrolled hypertension
• Urinary retention
• Children <2 yrs

• N/A

Renal Dose Adjustment (Based on CrCl)

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

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

Hepatic Dose Adjustment

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

• Pheniramine/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, advise patients to avoid such drugs and alcohol intake during therapy
• Discontinue therapy and consult a clinician if new symptoms occur, redness or swelling is noted, pain/nasal congestion worsens or lasts >7 days, fever gets worse or lasts >3 days; nervousness, dizziness or sleeplessness occurs; further evaluate the patients as these could be signs of a serious condition
• Antihistamine may produce paradoxical excitation in young children. Use of antihistamines is contraindicated in children <2 yrs

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Cardiovascular disease
• Arrhythmias
• Hypertension
• Hyperthyroidism
• Diabetes
• Increased IOP
• Angle-closure glaucoma
• History of asthma
• COPD
• Emphysema
• Chronic bronchitis
• Prostatic hypertrophy
• Bladder neck obstruction
• PUD
• GI obstruction
• Sodium-restricted diet
• CNS depressant use
• Chronic alcohol use
• Severe hypovolemia
• Chronic malnutrition
• Lower respiratory tract symptoms
• PKU (phenylalanine-containing forms)
• Concomitant use of anticoagulants
• Concomitant use of sedatives/tranquilizers
• Geriatric patients

Supplemental Patient Information

• Instruct patients to avoid driving a motor vehicle or operating machinery, as drowsiness may occur during therapy
• Advise patients to discontinue therapy and 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
• Advise patients to keep the medication out of reach of children
• Advise patients to seek medical help or contact a Poison Control Center in case of an overdose

Pregnancy Category:B (acetaminophen), C (pheniramine, 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 5 Dec 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 10 May 2011). Safety of pheniramine during breastfeeding is unknown. Manufacturer recommends consulting a healthcare professional before using this combination drug in nursing mothers.

• CNS: Drowsiness, dizziness, paradoxical CNS stimulation (in children), incoordination, headache, seizures, tremor, insomnia
• PSYCHIATRY: Toxic psychosis, anxiety
• CV: Hypertension, arrhythmias, hypotension, palpitations, tachycardia, reflex bradycardia
• RESP: Thickening of bronchial secretions
• GI: Hepatotoxicity, epigastric discomfort, constipation, nausea
• EENT: Blurred vision, diplopia, acute labyrinthitis
• DERM: Rash, diaphoresis
• HEMA: Hemolytic anemia, anemia, thrombocytopenia, agranulocytosis, pancytopenia, leukopenia
• GU: Urinary retention, dysuria, acute renal tubular necrosis, chronic analgesic nephropathy
• REPRODUCTIVE: Erectile dysfunction
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, photosensitivity
• MISC: Dry mucous membranes

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
• Rapidly and almost completely absorbed
• Metabolized by liver; CYP450: 2E1, 1A2, 2D6
• Excreted in urine 85% (5-10% unchanged)
• Half-life: 1.25-3 hrs

Pheniramine

• Antihistamine; antagonizes the pharmacological effects of histamine that are mediated through activation of H1 receptor sites and thereby reduces the intensity of allergic reactions and tissue injury response involving histamine release
• Metabolized in liver via hydroxylation, demethylation and glucuronidation
• Excretion: Unknown
• Half-life: Unknown

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)

• Theraflu Cold & Sore Throat
• Theraflu Flu & Sore Throat

US Availability

Theraflu Cold & Sore Throat (acetaminophen/pheniramine/phenylephrine)

• PWDR: 325 mg/20 mg/10 mg

Theraflu Flu & Sore Throat (acetaminophen/pheniramine/phenylephrine)

• PWDR: 650 mg/20 mg/10 mg

Canadian Trade Name(s)

• Extra Strength Neocitran Cold Night
• Neocitran Cold Night
• Rhume Et Grippe Extra-Fort
• Theraflu Cold And Flu

Canadian Availability

Extra Strength Neocitran Cold Night, Rhume Et Grippe Extra-Fort (acetaminophen/pheniramine/phenylephrine)

• PWDR: 650 mg/20 mg/10 mg

Neocitran Cold Night, Theraflu Cold And Flu (acetaminophen/pheniramine/phenylephrine)

• PWDR: 325 mg/20 mg/10 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Allergy/Cold

Antitussive, Combinations

ENT

Antitussive, Combinations