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Product Label Images

The following 6 images provide visual information about the product associated with Nuedexta NDC 64597-301 by Avanir Pharmaceuticals, Inc., such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

The structural formula for Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. - nuedexta 01

The structural formula for Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. - nuedexta 01

The structural formula for Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-o1, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. - nuedexta 02

The structural formula for Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-o1, 6’-methoxy-, (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. - nuedexta 02

Figure 1: Mean PBA Episode Rates by Visit - nuedexta 03

Figure 1: Mean PBA Episode Rates by Visit - nuedexta 03

Figure 2: Least Square Mean CNS-LS Scores by Visit - nuedexta 04

Figure 2: Least Square Mean CNS-LS Scores by Visit - nuedexta 04

The text appears to be from a clinical study or trial comparing the medication NUEDEXTA to a placebo. It includes some numerical data from days 15 and 20 of the trial and mentions statistical significance.*

PRINCIPAL DISPLAY PANELNDC 64597-301-60NUEDEXTA(dextromethorphan HBr and quinidine sulfate) capsules20 mg/ 10 mg60 capsulesRx Only - nuedexta 05

PRINCIPAL DISPLAY PANELNDC 64597-301-60NUEDEXTA(dextromethorphan HBr and quinidine sulfate) capsules20 mg/ 10 mg60 capsulesRx Only - nuedexta 05

NUEDEXTA is a medication in capsule form containing dextromethorphan HBr and quinidine sulfate used for the treatment of pseudobulbar affect (PBA). If you have any questions or comments about this medicine, you can call 1-655-458-3339. The usual dosage information can be found inside the package. The medication is manufactured and distributed by AV Pharmaceuticals, Inc. and should be kept out of the reach of children. Store the capsules at room temperature between 50°F-86°F. The product is copyrighted by Pharmaceuticals and is marked with the AVANIR trademark.*

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* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.