Comfort-Time

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: Comfort-Time
Generic name: ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE
Manufacturer: Time Cap Labs, Inc
Product type: HUMAN OTC DRUG
SPL set ID: e94a26a2-36e5-4e1e-aea1-24e035c98043
SPL ID: 7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5
Version: 3
Effective date: 2018-12-14
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:01

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		part343	openfda.application_number
brand name		Comfort-Time	openfda.brand_name
generic name		ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	openfda.generic_name
manufacturer name		Time Cap Labs, Inc	openfda.manufacturer_name
ndc	package	49483-347-24	openfda.package_ndc
ndc	product	49483-347	openfda.product_ndc
ndc11	package	49483034724	derived:openfda.package_ndc
rxcui		1597298	openfda.rxcui
spl id		7cfef4a4-ab1d-2dd4-e053-2991aa0a56c5	id
spl set id		e94a26a2-36e5-4e1e-aea1-24e035c98043	set_id
unii		3G6A5W338E	openfda.unii
unii		R35D29L3ZA	openfda.unii
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 · 2 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

warnings table

<table border="0" width="100%"> <tbody> <tr> <td> <paragraph>Warnings Liver warning: </paragraph> <paragraph>This product contains acetaminophen. Severe liver damage may occur if you take:</paragraph> <paragraph>more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product </paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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