CETAFEN COUGH and COLD

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: CETAFEN COUGH and COLD
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,
Manufacturer: HART Health
Product type: HUMAN OTC DRUG
SPL set ID: 44da0d8c-4a12-4122-99da-781e2809e1a8
SPL ID: 866ea7b4-cf9b-4001-a533-12b8f562e042
Version: 4
Effective date: 2025-12-24
Source export date: 2026-11-06
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:54:04

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M	openfda.application_number
brand name		CETAFEN COUGH and COLD	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	openfda.generic_name
manufacturer name		HART Health	openfda.manufacturer_name
ndc	package	50332-0141-7	openfda.package_ndc
ndc	package	50332-0141-3	openfda.package_ndc
ndc	package	50332-0141-4	openfda.package_ndc
ndc	product	50332-0141	openfda.product_ndc
ndc11	package	50332014107	derived:openfda.package_ndc
ndc11	package	50332014103	derived:openfda.package_ndc
ndc11	package	50332014104	derived:openfda.package_ndc
rxcui		1098435	openfda.rxcui
spl id		866ea7b4-cf9b-4001-a533-12b8f562e042	id
spl set id		44da0d8c-4a12-4122-99da-781e2809e1a8	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	openfda.unii
unii		362O9ITL9D	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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Reported adverse events (FAERS/openFDA)#

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