Maximum Strength Guaifenesin DM

NDC 0536-1213 · Rugby Laboratories

Generic nameGuaifenesin, Dextromethorphan HBr

Dosage formTABLET, EXTENDED RELEASE

RouteORAL

Active ingredient(s)DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN

Strength60; 1200 mg/1; mg/1

Pharmacologic classDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]

Marketing categoryANDA

Packages

0536-1213-88 — 14 BLISTER PACK in 1 CARTON (0536-1213-88) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Related Codes

Same active ingredient

FDA lists these products with the same active ingredient.

0363-9974 — Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, 0363-9975 — Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, 0363-9976 — Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, 0395-9126 — Dextromethorphan HBr, 0485-0171 — DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE, 0485-0204 — Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, 0485-0208 — GUAIFENESIN and PHENYLEPHRINE, 0485-0240 — CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE, 0536-1161 — Guaifenesin, Dextromethorphan HBr, 0536-1163 — Guaifenesin, 0536-1249 — Guaifenesin, 0536-1309 — Guaifenesin/phenylephrine, 0536-1311 — Guaifenesin, 0536-1312 — Dextromethorphan Hydrobromide / Guaifenesin, 0536-1313 — Dextromethorphan Hydrobromide, Guaifenesin, 0536-1314 — Guaifenesin, 0536-1333 — Guaifenesin and Pseudoephedrine Hydrochloride, 0536-1334 — Dextromethorphan HBr, 0536-1348 — dextromethorphan hydrobromide, guaifenesin, 0536-1392 — Guaifenesin, +2508 more

From the FDA National Drug Code Directory, retrieved August 24, 2026. Product listings are submitted by labelers; FDA does not verify them.