Adult Dosing

Symptoms of common cold/hay fever/other upper respiratory allergies

Benadryl Allergy Plus Cold, Benadryl Allergy Plus Sinus Headache, Sudafed PE Severe Cold

• 2 tabs (650 mg/25 mg/10 mg) PO q4 hrs
• Max: 12 tabs (3900 mg/150 mg/60 mg)/day

Benadryl Severe Allergy Plus Sinus Headache, Tylenol Allergy Multi-Symptom Nighttime

• 2 tabs (650 mg/50 mg/10 mg) PO q4 hrs
• Max: 12 tabs (3900 mg/300 mg/60 mg)/day

Robitussin Night Time Cough, Cold and Flu, Robitussin Peak Cold Nighttime Multi-Symptom Cold

• 20 mL PO q4 hrs PRN
• Max: 120 mL/day

Alka-Seltzer Plus Night Severe Cold, Cough & Flu, Theraflu Nighttime Severe Cold & Cough

• 1 packet (650 mg/25 mg/10 mg) PO q4 hrs prn
• Max: 6 packets (3900 mg/150 mg/60 mg)/day

Theraflu Warming Relief Flu & Sore Throat, Theraflu Warming Relief Nighttime Severe Cold and Cough

• 30 mL (650 mg/25 mg/10 mg) PO q4 hrs
• Max: 180 mL [3900 mg/150 mg/60 mg]/day

Pediatric Dosing

Symptoms of the common cold/hay fever/other upper respiratory allergies

Benadryl Allergy Plus Cold, Benadryl Allergy Plus Sinus Headache, Sudafed PE Severe Cold

• >12yrs
• 2 tabs (650 mg/25 mg/10 mg) PO q4 hrs
• Max: 12 tabs (3900 mg/150 mg/60 mg)/day

Benadryl Severe Allergy Plus Sinus Headache, Tylenol Allergy Multi-Symptom Nighttime

• >12yrs
• 2 tabs (650 mg/50 mg/10 mg) PO q4 hrs
• Max: 12 tabs (3900 mg/300 mg/60 mg)/day

Children's Tylenol Plus Cold & Allergy

• <4 yrs, <36 lbs
• Safety and effectiveness has not been established

• 4-5 yrs, 36-47 lbs
• Do not use unless directed by a physician

• 6-11 yrs, 48-95 lbs
• 10 mL (320 mg/25 mg/5 mg) PO q4 hrs
• Max: 60 mL (1920 mg/150 mg/30 mg

Robitussin Night Time Cough, Cold and Flu, Robitussin Peak Cold Nighttime Multi-Symptom Cold

• >12 yrs
• 20 mL PO q4 hrs PRN
• Max: 120 mL/day

Theraflu Nighttime Severe Cold & Cough

• >12 yrs
• 1 packet (650 mg/25 mg/10 mg) PO q4 hrs prn
• Max: 6 packets (3900 mg/150 mg/60 mg)/day

Theraflu Warming Relief Flu & Sore Throat, Theraflu Warming Relief Nighttime Severe Cold and Cough

• >12 yrs
• 30 mL (650 mg/25 mg/10 mg) PO q4 hrs
• Max: 180 mL [3900 mg/150 mg/60 mg]/day

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of symptoms associated with the common cold or hay fever or other upper respiratory allergies such as:
• Runny nose
• Stuffy nose
• Nasal congestion
• Headache
• Sore throat
• Cough due to minor throat and bronchial infection
• Sneezing
• Minor aches and pains
• Itchy, watery eyes
• Itching of the nose or throat
• Sinus congestion and pressure
• Temporarily reduces fever

• Hypersensitivity to any of the ingredients of the product
• Co-administration with other acetaminophen- or diphenhydramine-containing products
• Pediatric patients <12 yrs of age
• Concomitant use of monoamine oxidase inhibitor or use within 14 days of stopping MAOI therapy
• 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

• Diphenhydramine
• Renal impairment: Dose adjustments not defined

• Phenylephrine
• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

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

• Diphenhydramine
• Hepatic impairment: Dose adjustments not defined

• Phenylephrine
• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Acetaminophen component of this combination drug 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
• Instruct patients not to use this combination drug with any other drugs containing acetaminophen or diphenhydramine. Instruct patients to avoid concurrent use of this drug with MAO inhibitors or within 14 days of stopping MAOI therapy
• Undertake detailed medical history of patients for presence of any liver disease, breathing problems such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, urinary obstruction, or prostatic hypertrophy; before initiating therapy, ask patients if they are receiving any blood thinning agents such as warfarin, sedatives or tranquilizers
• All patients undergoing treatment especially children are prone to excitability
• Significant drowsiness may occur during therapy; avoid concomitant use of alcoholic beverages, alcohol, sedatives and tranquilizers as they may worsen drowsiness
• Instruct patients to exercise caution while driving a motor vehicle or operating machinery
• 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, or if nervousness, dizziness or sleeplessness occurs; further evaluate the patients as these could be signs of a serious condition
• Instruct patients to immediately cease use of this product if cough comes back with a fever, rash, or headache
• Instruct patients to immediately contact a Poison Control Center in case of overdose

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Arrhythmias
• Heart disease
• Asthma
• Smoking
• Bladder neck obstruction
• CNS depressant use
• GI obstruction
• High environmental temperature
• Severe hypovolemia
• Elevated IOP
• Lower respiratory tract symptoms
• Chronic malnutrition
• PKU (phenylalanine-containing forms)
• Poor CYP2D6 metabolizer
• Peptic ulcer disease
• Elderly patients
• Cough with too much phlegm

Supplemental Patient Information

• Advise patients to consult their clinician/pharmacist if they are unsure whether a drug contains acetaminophen
• Instruct patients undergoing treatment to exercise caution while driving a motor vehicle or operating machinery
• Advise women of childbearing potential to stop use of this combination drug if they are pregnant, breastfeeding, or having intention of becoming pregnant
• Inform patients to keep this drug out of reach of children
• Instruct patients to avoid alcoholic beverages during therapy

Pregnancy Category:B (acetaminophen), B (diphenhydramine), 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. Small, occasional doses of diphenhydramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply, particularly when used in combination with a sympathomimetic agent or when lactation is not well established. The nonsedating antihistamines are preferred alternatives. 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 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 9 Dec, 2011). Manufacturer advises to consult a health professional.

• CNS: Confusion, severe dizziness, restless feeling, nervousness, seizures, tremor, drowsiness, headache, excitability, insomnia, paradoxical CNS stimulation
• PSYCHIATRY: Toxic psychosis, anxiety
• CV: Arrhythmia, hypertension, chest pain, palpitations, tachycardia
• GU: Chronic analgesic nephropathy, acute renal tubular necrosis, less urination, dysuria, urinary retention
• RESP: Thickened bronchial secretions
• REPRODUCTIVE: Erectile dysfunction
• EENT: Acute labyrinthitis, blurred vision, diplopia
• GI: Hepatotoxicity, nausea, epigastric discomfort, constipation
• DERM: Skin rash, diaphoresis
• HEMA: Agranulocytosis, hemolytic anemia, anemia, leukopenia, pancytopenia, thrombocytopenia
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, photosensitivity
• MISC: 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

Diphenhydramine

• I generation antihistamine; non-selectively antagonizes histamine at H1 receptor sites, exhibits anticholinergic properties producing significant CNS depression
• Well absorbed
• Extensively metabolized by liver; CYP450: 2D6, 1A2, 2C9, 2C19
• Renally excreted
• Half-life: 1-4 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 Night Severe Cold
• Cough & Flu
• Benadryl Allergy Plus Cold
• Benadryl Allergy Plus Sinus Headache
• Benadryl Severe Allergy Plus Sinus Headache
• Children's Tylenol Plus Cold and Allergy
• Robitussin Night Time Cough
• Cold and Flu
• Robitussin Peak Cold Nighttime Multi-Symptom Cold
• Sudafed PE Severe Cold
• Theraflu Nighttime Severe Cold & Cough
• Theraflu Warming Relief Flu & Sore Throat
• Theraflu Warming Relief Nighttime Severe Cold & Cough
• Tylenol Allergy Multi-Symptom Nighttime

US Availability

Benadryl Allergy Plus Cold, Benadryl Allergy Plus Sinus Headache, Sudafed PE Severe Cold (acetaminophen/diphenhydramine/phenylephrine)

• OTC TABS: 325 mg/12.5 mg/5 mg

Benadryl Severe Allergy Plus Sinus Headache, Tylenol allergy multi-symptom nighttime (acetaminophen/diphenhydramine/phenylephrine)

• OTC TABS: 325 mg/25 mg/5 mg

Children's Tylenol Plus Cold and Allergy (acetaminophen/diphenhydramine/phenylephrine)

• OTC SUSP: [160 mg/12.5 mg/2.5 mg]/5 mL

Robitussin Night Time Cough, Cold and Flu, Robitussin Peak Cold Nighttime Multi-Symptom Cold (acetaminophen/diphenhydramine/phenylephrine)

• OTC SOLN: [160 mg/6.25 mg/2.5 mg]/5 mL

Alka-Seltzer Plus Night Severe Cold, Cough & Flu, Theraflu Nighttime Severe Cold & Cough (acetaminophen/diphenhydramine/phenylephrine)

• OTC PWDR: [650 mg/25 mg/10 mg]/packet

Theraflu Warming Relief Flu & Sore Throat, Theraflu Warming Relief Nighttime Severe Cold & Cough (acetaminophen/diphenhydramine/phenylephrine)

• OTC SOLN: [325 mg/12.5 mg/5 mg]/15 mL

Tylenol Allergy Multi-Symptom Nighttime (acetaminophen/diphenhydramine/phenylephrine)

• OTC TABS: 325 mg/25 mg/5 mg

Canadian Trade Name(s)

• Benylin All-in-One Cold and Flu Night PE Caplets
• Extra Strength Neocitran Flu Syrup
• Extra Strength Neocitran Total Symptom Relief - Sugar Free

Canadian Availability

Benylin All-in-One Cold and Flu Night PE Caplets (acetaminophen/diphenhydramine/phenylephrine)

• OTC TABS: 325 mg/25 mg/5 mg

Extra Strength Neocitran Flu Syrup (acetaminophen/diphenhydramine/phenylephrine)

• OTC SYRUP: [650 mg/25 mg/10 mg]/30 mL

Extra Strength Neocitran Total Symptom Relief - Sugar Free (acetaminophen/diphenhydramine/phenylephrine)

• OTC POWD: [650 mg/25 mg/10 mg]/packet

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