Night Time Severe Cold and Flu

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: Night Time Severe Cold and Flu
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
Manufacturer: Walgreen Company
Product type: HUMAN OTC DRUG
SPL set ID: de2b2e34-62a5-451f-ab68-531d1c9d4d82
SPL ID: 6e90a856-b1f6-4a6e-bf4c-b341d3e1cee7
Version: 3
Effective date: 2023-12-29
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:52:46

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Night Time Severe Cold and Flu	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Walgreen Company	openfda.manufacturer_name
ndc	package	0363-0331-26	openfda.package_ndc
ndc	product	0363-0331	openfda.product_ndc
ndc11	package	00363033126	derived:openfda.package_ndc
rxcui		1431245	openfda.rxcui
spl id		6e90a856-b1f6-4a6e-bf4c-b341d3e1cee7	id
spl set id		de2b2e34-62a5-451f-ab68-531d1c9d4d82	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	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 in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away. 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.