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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217338

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NDA 217338 describes MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM, which is a drug marketed by Rb Hlth and is included in one NDA. Additional details are available on the MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM profile page.

The generic ingredient in MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM is dextromethorphan hydrobromide; guaifenesin; naproxen sodium. There are twenty-three drug master file entries for this compound. Additional details are available on the dextromethorphan hydrobromide; guaifenesin; naproxen sodium profile page.

Summary for 217338

Tradename:	MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
Applicant:	Rb Hlth
Ingredient:	dextromethorphan hydrobromide; guaifenesin; naproxen sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG;600MG;110MG
Approval Date:	Dec 22, 2025	TE:		RLD:	Yes

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