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Side Effects & Adverse Reactions
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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)].
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:
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:
Sources
Tuzistra Xr Manufacturers
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Vernalis Therapeutics, Inc.
Tuzistra Xr | Vernalis Therapeutics, Inc.
2.1 Adults 18 Years of Age and OlderTUZISTRA XR should be orally administered in a dose of 10 mL every 12 hours, not to exceed 2 doses (20 mL) in 24 hours.
2.2 Administration InformationAdminister TUZISTRA XR by the oral route only, with or without food. Shake well before use. Measure with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.8)].
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