FDA label
What is Tuxarin used for?
Tuxarin contains codeine and chlorpheniramine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.”
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Tuxarin, tablet, extended release
Indications and Usage, quoted from the label by Mainpointe Pharmaceuticals (NDA206323). Cross-references to other label sections are left out.
TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
- Not indicated for pediatric patients under 18 years of age.
- Contraindicated in pediatric patients under 12 years of age.
- Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy.
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve TUXARIN ER for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Source: DailyMed label, set id a7cfab67-6087-4ab4-b7cd-4f9295413180, version 6, effective January 10, 2024. NDC 71269-040, one of 1 listing for this product.
Questions
What is Tuxarin used for?
The FDA label says: “TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.”
What drug class is Tuxarin?
FDA lists codeine and chlorpheniramine in the Histamine-1 Receptor Antagonist and Opioid Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Tuxarin
- Is Tuxarin a controlled substance?Schedule III
- Is Codeine and Chlorpheniramine a controlled substance?Schedule III
- Generic for Tuxarin ERFDA Orange Book
- Histamine-1 Receptor Antagonists listFDA drug class
- Opioid Agonists listFDA drug class
- NDC 71269-040Tuxarin NDC record
- Schedule III drugs listDEA schedule