SPL Set ID: 60a2834c-38a2-480e-b89c-563e9cf0c9c3

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levoamphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain two types of drug-containing beads (immediate-release and delayed release) which prolongs the release of amphetamine compared to the conventional Mixed Salts of a Single-Entity Amphetamine Product Tablets (immediate-release) tablet formulation. Each capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d -amphetamine base equivalence l -amphetamine base equivalence 2.4 mg 0.75 mg 4.7 mg 1.5 mg 7.1 mg 2.3 mg 9.5 mg 3.0 mg 11.9 mg 3.8 mg 14.2 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules include: hard gelatin capsules, hydroxypropyl cellulose, methacrylic acid-ethyl acrylate copolymer, sucrose, corn starch, talc, triethyl citrate, sodium lauryl sulfate, and polysorbate 80. The gelatin capsules for all six strengths contain gelatin, titanium dioxide, sodium lauryl sulfate, and edible inks containing shellac glaze, propylene glycol, ferrosoferric oxide, and black iron oxide. The 5 mg contains FD&C Blue No. 1, D&C Red No. 28, FD&C Yellow 6, and D&C Yellow 10. The 10 mg and 15 mg capsules contain FD&C Blue No. 1 and D&C Red No. 28. The 20 mg, 25 mg, and 30 mg capsules contain FD&C Yellow 6 and D&C Yellow 10.