Pillstats
OTC · Kit

Dextromethorphan Hbr, Guaifenesin, Acetaminophen, Doxylamine Succinate

Brands: Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack

1 ACTIVE SUPPLIER — US
openFDA · updated weekly
US1 NDCs
1 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)3642
US makers1 labelers
Packages1
DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it1 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Genexa Inc.unknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Sep 25, 2024
    RECALLRecall (Class III): Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles fur…

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Recalling firm: Denison Pharmaceuticals, LLC — Product was distributed to two accounts that may have distributed the product further to the Retail Level.

  • Sep 25, 2024
    RECALLRecall (Class III): Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fu…

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. — Recalling firm: Denison Pharmaceuticals, LLC — Product was distributed to two accounts that may have distributed the product further to the Retail Level.