Zotex-c

Zotex-c

Zotex-c Recall

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Questions & Answers

Side Effects & Adverse Reactions

Do not exceed the recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

If a hypertensive crisis occurs, these drugs should be discontiued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Zotex™-C Syrup is indicated for symptomatic relief of coughs and upper respiratory symptoms. Including nasal congestion, associated the common cold.

History

There is currently no drug history available for this drug.

Other Information

Zotex™-C Syrup is an antitussive decongestant and antihistamine available for oral administration as a syrup.

Each 5 mL (1 teaspoonful) of red-colored, cherry-flavored syrup contains:

Codeine Phosphate
(WARNING-May be habit forming)
10 mg
Phenylephrine Hydrochloride 5 mg
Pyrilamine Maleate 5 mg

Inactive Ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, FD&C Red #40, Cherry Flavor, Purified Water.

Codeine Phosphate is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white crystalline powder. It is affected by light. Its chemical name is Morphinan-6-ol, 7,8-didehydroxy-4,5-epoxy-3-methoxy-17-methyl- ,(5α,6α)-, phosphate (1:1) (salt), hemihydrate.

Its structure is as follows:

Chemical Structure

C12H21NO3 • H3PO4½H2O                              M.W. 406.37

Phenylephrine Hydrochloride is a sympathomimatic amine decongestant which occurs as white or practically white, odorless crystals having a bitter taste. It is freely soluble in water and in alcohol. The chemical name is: Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-hydrochloride (R)-. Its structure is as follows:

Chemical Structure

C9H13NO2 • HCl                              M.W. 203.67

Pyrilamine Maleate is an antihistamine having the chemical name 2-[(2-Dimethylamino)ethyl)(p-methoxybenzyl)amino] pyridine maleate (1:1). Its structural formula is as follows:

Chemical Structure

C17H23N3O•C4H4O4                              MW 401.47

Zotex-c Manufacturers


  • Vertical Pharmaceuticals, Inc.
    Zotex-c (Codeine Phosphate, Phenylephrine Hydrochloride And Pyrilamine Maleate) Syrup [Vertical Pharmaceuticals, Inc.]

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