acetaminophen/chlorpheniramine/dextromethorphan (Children's Triaminic Flu, Cough and Fever, Children's Tylenol Plus Cough and Runny Nose, Coricidin HBP Maximum Strength Flu, Vicks Formula 44 Custom Care Cough and Cold PM, St. Joseph Maximum Strength Flu)

Dosing and uses of Children's Triaminic Flu, Cough and Fever, Children's Tylenol Plus Cough and Runny Nose (acetaminophen/chlorpheniramine/dextromethorphan)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/chlorpheniramine/dextromethorphan

tablet

• 500mg/2mg/15mg

 

Relief of Cold & Flu Symptoms

2 tab PO q6hr; not to exceed 8 tabs/day

 

Pediatric dosage forms and strengths

acetaminophen/chlorpheniramine/dextromethorphan

tablet

• 500mg/2mg/15mg

 

Relief of Cold & Flu Symptoms

≥12 years: 2 tablets PO q6hr; not to exceed 8 tabs/day

 

Children's Triaminic Flu, Cough and Fever, Children's Tylenol Plus Cough and Runny Nose (acetaminophen/chlorpheniramine/dextromethorphan) adverse (side) effects

Frequency not defined

Hypotension

Palpitations

Tachycardia

Confusion

Depression

Distress

Dizziness

Euphoria

Fatigue

Headache

Insomnia

Irritability

Sedation

Tremors

Dermatologic rash

Anorexia

GI disturbances

Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Agranulocytosis

Hemolytic anemia

Thrombocytopenia

Bilirubin and alkaline phosphatase may increase

Thickening of bronchial secretions

Wheezing

 

Warnings

Contraindications

Contraindicated in documented hypersensitivity; asthma attacks, narrow-angle glaucoma, symptomatic prostate hypertrophy, bladder-neck obstruction, and stenosing peptic ulcer; known G-6-PD deficiency

Chlorpheniramine may cause significant confusional symptoms; not for administration to < 2 years of age

Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

Do not take dextromethorphan for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; dextromethorphan may slow the breathing

 

Cautions

Caution in asthma, bladder neck obstruction, cardiovascular disease, COPD, GI obstruction, glaucoma, hepatic impairment, hypertension, hyperthyroidism, increased intraocular pressure, malnutrition, renal impairment, elderly patients, patients taking CNS depressants or <6 years of age with chlorpheniramine products

Caution in severe hypovolemia if taking acetaminophen products

Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

 

Pregnancy and lactation

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Children's Triaminic Flu, Cough and Fever, Children's Tylenol Plus Cough and Runny Nose (acetaminophen/chlorpheniramine/dextromethorphan)

Mechanism of action

Chlorpheniramine blocks muscle responses in histamine and acts as an antagonism of the constrictor effects of histamine on respiratory smooth muscle

Acetaminophen blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS. Reduces fever by inhibiting the hypothalamic heat-regulating center

Dextromethorphan is a cough suppressant that acts centrally on the cough center in the medulla