AMPHETAMINE SULFATE
Amphetamine Sulfate Tablets, USP, CII
89c5b52f-3c2a-41d5-8624-9ee51c512c72
HUMAN PRESCRIPTION DRUG LABEL
Sep 26, 2023
Solco Healthcare US, LLC
DUNS: 828343017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
amphetamine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
Amphetamine sulfate tablets, USP, are supplied as follows:
**5 mg:**White, round, convex tablet, uppers scored and debossed "5" on the left side, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-457-10.
**10 mg:**White, round, convex tablet, uppers are double crossed scored and debossed "1" on the lower left corner and "0" on the lower right corner, lowers debossed "S" in bottles of 100 tablets with child-resistant closure, NDC 43547-458-10.
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15oC and 30oC (59oF and 86oF). [see USP Controlled Room Temperature.] Dispense in a well- closed container, as defined in the USP.
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/amphetamine- tablets.pdf
Manufactured by:
Prinston Laboratories
Charlotte, NC 28206, USA
Distributed by:
Solco Healthcare US, LLC
Somerset, NJ 08873, USA
Revised: 09/2023
9040380-06