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Deconsal

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Deconsal DM

Warnings
Precautions

WARNINGS

This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

PRECAUTIONS

General

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma.

Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term animal studies have been performed with Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets.

Pregnancy

Teratogenic Effects- Pregnancy Category C

Animal reproduction studies have not been conducted with Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets. It is also not known whether Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Chewable Tablets should be given to a pregnant woman only if clearly needed.

Labor and Delivery

Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Deconsal® DM (phenylephrine, pyrilamine maleate, and dextromethorphan hbr) Tannate Tablets should not be administered to a nursing mother.

Last reviewed on RxList: 5/4/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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