Nite-Time COLD/FLU Medicine

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: Nite-Time COLD/FLU Medicine
Generic name: ACETAMINOPHEN
Manufacturer: AptaPharma Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 344440bc-d810-4296-93ec-e6ae6673856b
SPL ID: 46e2c8b6-bd83-7100-e063-6294a90ac998
Version: 9
Effective date: 2025-12-26
Source export date: 2026-10-27
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:58:46

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Nite-Time COLD/FLU Medicine	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		AptaPharma Inc.	openfda.manufacturer_name
ndc	package	76281-501-28	openfda.package_ndc
ndc	package	76281-501-25	openfda.package_ndc
ndc	product	76281-501	openfda.product_ndc
ndc11	package	76281050125	derived:openfda.package_ndc
ndc11	package	76281050128	derived:openfda.package_ndc
rxcui		1043400	openfda.rxcui
spl id		46e2c8b6-bd83-7100-e063-6294a90ac998	id
spl set id		344440bc-d810-4296-93ec-e6ae6673856b	set_id
unii		9D2RTI9KYH	openfda.unii
unii		V9BI9B5YI2	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 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks everyday while using this product. 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 promptly.

Reported adverse events (FAERS/openFDA)#

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