Adult Dosing

Cough, nasal congestion, hay fever, and other upper respiratory allergies

• 20 mL (4 tsp) PO q4hrs PRN. Max: 120 mL/day

Note:

• Use only the dosing cup enclosed with this product

Pediatric Dosing

Cough, nasal congestion, hay fever, and other upper respiratory allergies

• Children <6 yrs: Avoid use
• Children 6 to <12 yrs: 10 mL (2 tsp) PO q4hrs PRN. Max: 60 mL/day
• Children >12 yrs: 20 mL (4 tsp) PO q4hrs PRN. Max: 120 mL/day

Note:

• Use only the dosing cup enclosed with this product

[Outline]

• Adult Dosing
• Pediatric Dosing

• Temporary relief of cough due to minor throat and bronchial irritation occurring with a cold and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves symptoms due to hay fever including
• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

• Temporarily restores freer breathing through the nose

• Hypersensitivity to any of the ingredients of the product
• Concomitant use of monoamine oxidase inhibitor (MAOI) or within 2 wks of stopping MAOI
• Concomitant use with other drugs containing decongestants or cough suppressants
• Patients <2 yrs
• Uncontrolled or severe hypertension
• Coronary artery disease
• Urinary retention

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Do not exceed recommended dose
• Avoid concomitant use of other oral nasal decongestant or stimulant
• Therapy may cause marked drowsiness. Hence, advise patients not to drive a motor vehicle or operate machinery during therapy
• Avoid using this product to sedate a child or to make a child sleepy
• Children are prone to excitability during therapy
• Avoid alcoholic beverages during therapy, as alcohol may increase drowsiness
• Sedatives and tranquilizers may increase drowsiness; avoid concomitant use with such agents
• Therapy may cause nervousness, dizziness, or sleeplessness; discontinue the drug and consult a physician if such symptoms occur
• Discontinue therapy and consult a clinician if symptoms do not improve within 1 week or occur with a fever; cough gets worse or persists for more than 7 days or if cough comes back or occurs with fever, rash or persistent headache; further evaluate the patients as these could be signs of a serious condition
• Keep out of reach of children. In case of overdose, promptly seek medical attention or contact a Poison Control Center

Cautions: Use cautiously in

• Renal impairment
• Arrhythmias
• Asthma
• Bladder neck obstruction
• Cardiovascular disease
• CNS depressant use
• COPD
• Diabetes mellitus
• GI obstruction
• Angle-closure glaucoma
• High environmental temperature
• Hypertension
• Thyroid disease
• Elevated IOP
• Lower respiratory tract symptoms
• PKU (phenylalanine-containing forms)
• Prostatic hypertrophy
• PUD
• Elderly patients
• Cough with excessive phlegm
• Persistent or chronic cough such as occurs with asthma, smoking, or emphysema

Supplemental Patient Information

• Inform patients to avoid alcoholic beverages during therapy
• Instruct patients to exercise caution when driving a motor vehicle or operating machinery

Pregnancy Category:C (brompheniramine), C (dextromethorphan), C (phenylephrine)

Breastfeeding: No adverse effects are seen in breastfed infants with small, occasional doses of brompheniramine. However, larger doses or more prolonged use can cause effects in the infant or decrease the milk supply, particularly when used with a sympathomimetic such as pseudoephedrine or before lactation is well established. After the last feeding of the day, single bedtime dose may be adequate for many women and will minimize any effects of the drug. The preferred alternatives are nonsedating antihistamines. 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 use of products with a 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 last accessed 16 August 2011). Manufacturer advises to consult a health professional.

• CV: Cardiac arrhythmias, hypertension, hypotension, palpitations, tachycardia
• CNS: Serotonin syndrome, abuse potential, anxiety, CNS stimulation, paradoxical CNS stimulation, seizures, incoordination, dizziness, drowsiness, excitation (especially in children), fatigue, headache, insomnia, nervousness, restlessness, sedation, tremor
• PSYCHIATRY: Toxic psychosis
• DERM: Excessive perspiration, pruritus, rash, urticaria
• EENT: Acute labyrinthitis, blurred vision, diplopia
• GI: Constipation, dry mucous membranes, abdominal pain, epigastric discomfort, nausea, vomiting
• GU: Dysuria, urinary retention, erectile dysfunction
• HEMA: Agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia
• HYPERSENSITIVITY: Anaphylactic/anaphylactoid reactions, photosensitivity
• RESP: Thickened bronchial secretions
• MISC: Diaphoresis, heat stroke

Brompheniramine

• Histamine H1 antagonist; non-selectively antagonizes central and peripheral histamine H1 receptors, and also functions as a moderately effective anticholingeric agent
• Well absorbed from the GI tract after oral administration
• Metabolized by liver; CYP450: None
• Renally excreted 40% (5-10% unchanged), feces 2%
• Half-life: 12-35 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)

• Children's Dimetapp Cold & Cough

US Availability

Children's Dimetapp Cold & Cough (brompheniramine/dextromethorphan/phenylephrine)

• OTC SOLN: [1 mg/5 mg/2.5 mg]/5 mL

Canadian Trade Name(s)

• Dimetapp DM Cough & Cold
• Dimetapp Extra Strength DM Cough & Cold
• DM Cough and Cold Liquid
• DM Cough and Cold Relief
• DM Cough and Cold Syrup
• Extra Strength DM Cough and Cold Liquid
• Extra Strength DM Cough and Cold Syrup
• Runny Nose and Cough

Canadian Availability

Dimetapp DM Cough & Cold, DM Cough and Cold Liquid (brompheniramine/dextromethorphan/phenylephrine)

• OTC LIQ: [2 mg/10 mg/5 mg]/5 mL

Dimetapp Extra Strength DM Cough & Cold, DM Cough and Cold Relief, Extra Strength DM Cough and Cold Liquid (brompheniramine/dextromethorphan/phenylephrine)

• OTC LIQ: [4 mg/20 mg/10 mg]/5 mL

DM Cough and Cold Syrup (brompheniramine/dextromethorphan/phenylephrine)

• OTC SYRUP: [2 mg/10 mg/5 mg]/5 mL

Extra Strength DM Cough and Cold Syrup (brompheniramine/dextromethorphan/phenylephrine)

• OTC SYRUP: [4 mg/20 mg/10 mg]/5 mL

Runny Nose and Cough (brompheniramine/dextromethorphan/phenylephrine)

• OTC LIQ: [1 mg/5 mg/2.5 mg]/5 mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Demazin Cough & Cold Relief

Australian Availability

Demazin Cough & Cold Relief (brompheniramine/dextromethorphan/phenylephrine)

• OTC SYRUP: [2 mg/10 mg/5 mg]/5 mL

[Outline]

Allergy/Cold

Cough/Cold Non-Narcotic Combinations

ENT

Cough/Cold Non-Narcotic Combinations