SEVERE CONGESTION and COUGH MAX

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: SEVERE CONGESTION and COUGH MAX
Generic name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: DeMoulas Market Basket
Product type: HUMAN OTC DRUG
SPL set ID: cdd53eba-1fa2-49c1-b03d-c32f309da7fb
SPL ID: ebcae6ad-1c5f-4599-821d-e1b5ce0a96f2
Version: 1
Effective date: 2026-05-08
Source export date: 2026-11-06
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:45:41

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		SEVERE CONGESTION and COUGH MAX	openfda.brand_name
generic name		DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		DeMoulas Market Basket	openfda.manufacturer_name
ndc	package	53942-517-25	openfda.package_ndc
ndc	product	53942-517	openfda.product_ndc
ndc11	package	53942051725	derived:openfda.package_ndc
rxcui		1043543	openfda.rxcui
spl id		ebcae6ad-1c5f-4599-821d-e1b5ce0a96f2	id
spl set id		cdd53eba-1fa2-49c1-b03d-c32f309da7fb	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		495W7451VQ	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings • Do not use ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • For children under 12 years of age

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.