Tuzistra Xr

Tuzistra Xr

Tuzistra Xr Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

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

1.1 Cough and Upper Respiratory Allergy Symptoms

TUZISTRA XR is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations(8.4)].

1.1 Cough and Upper Respiratory Allergy Symptoms

TUZISTRA XR is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations(8.4)].

History

There is currently no drug history available for this drug.

Other Information

TUZISTRA XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension is a pink to reddish pink, cherry-flavored liquid suspension that contains an opiate agonist antitussive codeine and a histamine-1 (H1) receptor antagonist (antihistamine) chlorpheniramine.  Each 5 mL of TUZISTRA XR contains 14.7 mg of codeine (equivalent to 20 mg of codeine phosphate) and 2.8 mg of chlorpheniramine (equivalent to 4 mg of chlorpheniramine maleate) bound to sulfonated styrene-divinylbenzene copolymer (polistirex).

TUZISTRA XR contains the following inactive ingredients: cherry flavor, citric acid, D&C Red No. 30, ethyl maltol, glycerin, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propyl gallate, propylparaben, purified water, sodium citrate, sodium polystyrene sulfonate, starch, sucrose, triacetin, xanthan gum.

Codeine is (5α,6α)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol, has the following molecular formula, C18H21NO3, and a molecular weight of 299.36.  Codeine polistirex is a complex of codeine with sulfonated styrene-divinylbenzene copolymer, having the following structural formula:

 Codeine structural formula

Chlorpheniramine is γ-(4-chlorophenyl)-N, N-dimethyl-2-pyridinepropanamine, has the following molecular formula, C16H19ClN2, and a molecular weight of 274.80.  Chlorpheniramine polistirex is a complex of chlorpheniramine with sulfonated styrene-divinylbenzene copolymer, having the following structural formula:

Chlorpheniramine following structural

Tuzistra Xr Manufacturers


  • Vernalis Therapeutics, Inc.
    Tuzistra Xr (Codeine Polistirex And Chlorpheniramine Polistirex) Suspension, Extended Release [Vernalis Therapeutics, Inc.]

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