A pediatric patient may die or have a serious complication after receiving a cough or cold remedy if certain risk factors are present.


Risk factors for a serious complication following treatment of a pediatric patient with a cough or cold remedy:

(1) administering too high a dose by guessing, extrapolating or other cognitive error

(2) repeating a dose too often

(3) having renal insufficiency or other disorder that reduces drug clearance

(4) assuming that an over-the-counter (OTC) drug is safe

(5) administering a remedy to a patient for which the drug is not approved (infant, other)

(6) drug-drug interaction

(7) administering more than 1 remedy containing the same drug

(8) allergy

(9) failing to closely observe the patient

(10) not following instructions

(11) multiple caregivers


A drug reaction needs to be distinguished from the underlying disease.


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