CETAFEN EXTRA

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 EXTRA
Generic name: ACETAMINOPHEN
Manufacturer: HART Health
Product type: HUMAN OTC DRUG
SPL set ID: 38db0b09-37f8-4fed-903e-81e89486b39b
SPL ID: 0f2b113c-48f1-4a6f-8d6b-89c82a28e646
Version: 3
Effective date: 2025-12-24
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:12:54

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 · 20 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M	openfda.application_number
brand name		CETAFEN EXTRA	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		HART Health	openfda.manufacturer_name
ndc	package	50332-0149-7	openfda.package_ndc
ndc	package	50332-0149-4	openfda.package_ndc
ndc	package	50332-0149-3	openfda.package_ndc
ndc	package	50332-0149-8	openfda.package_ndc
ndc	package	50332-0149-1	openfda.package_ndc
ndc	product	50332-0149	openfda.product_ndc
ndc11	package	50332014907	derived:openfda.package_ndc
ndc11	package	50332014901	derived:openfda.package_ndc
ndc11	package	50332014904	derived:openfda.package_ndc
ndc11	package	50332014908	derived:openfda.package_ndc
ndc11	package	50332014903	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
rxcui		1358835	openfda.rxcui
spl id		0f2b113c-48f1-4a6f-8d6b-89c82a28e646	id
spl set id		38db0b09-37f8-4fed-903e-81e89486b39b	set_id
unii		362O9ITL9D	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 rash blisters

Reported adverse events (FAERS/openFDA)#

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