Nighttime Cold and Flu Max Softgels

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: Nighttime Cold and Flu Max Softgels
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
Manufacturer: Topco Associates, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 787bff76-0ee2-4e7e-b908-876e4a3e3bfc
SPL ID: 4279e8f6-12b1-b3c3-e063-6394a90a54cf
Version: 4
Effective date: 2025-10-31
Source export date: 2026-11-06
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/2026-11-06/9d5577a314a25811fefbde4767c9b37f3913d9a65fdc458c6336b5aed532339e/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:50:14

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		M012	openfda.application_number
brand name		Nighttime Cold and Flu Max Softgels	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Topco Associates, LLC	openfda.manufacturer_name
ndc	package	76162-913-24	openfda.package_ndc
ndc	product	76162-913	openfda.product_ndc
ndc11	package	76162091324	derived:openfda.package_ndc
spl id		4279e8f6-12b1-b3c3-e063-6394a90a54cf	id
spl set id		787bff76-0ee2-4e7e-b908-876e4a3e3bfc	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 8 Softgels in 24 hrs, which is the maximum daily amount for this product • 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.