"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, death. Codeine may cause or aggravate constipation. Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
Because of its antihistamine component, this product should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, this product should be used with caution in patients with diabetes, hypertension, heart disease or thyroid disease.
Informatlon for Patients
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of phenylpropanolamine. Sympathomimetics may reduce the effects of antihypertensive drugs.
Long-term studies in animals to evaluate carcinogenic and mutagenic potential have not been performed.
Pregnancy Category C
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (one of the components of this product) in rats and mice at doses up to 16 times the maximum human dose have revealed no evidence of impaired fertility or harm to the fetus.
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, and the fact that codeine appears in human milk, this product is contraindicated in nursing mothers.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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