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OTC · Solution · Oral

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Brands: Maximum Strength Mucinex Fast-Max Cold And Flu · Mucinex Childrens Cold And Flu · Mucinex Childrens Freefrom Multi-Symptom Cold, Flu And Sore Throat · Mucinex Childrens Multi-Symptom Cold And Sore Throat +5 · Acetaminophen + Dextromethorphan Hydrobromide + Guaifenesin + Phenylephrine Hydrochloride

4 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US9 NDCs
4 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
RxCUI (US)3289
US makers4 labelers
Packages14
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 it4 active · 0 exited

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

LabelerTypePackagesStatus
Reckitt Benckiser LLCunknown6SUPPLYING
The Procter & Gamble Manufacturing Companyunknown5SUPPLYING
Kenvue Brands LLCunknown2SUPPLYING
RB Health (US) LLCunknown1SUPPLYING

Regulatory & supply eventsFDA · US

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

  • Apr 15, 2015
    RECALLRecall (Class I): Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan…

    Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. — Recalling firm: Reckitt Benckiser LLC — Nationwide