Daytime Cold and Flu Max Maximum Strength 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: Daytime Cold and Flu Max Maximum Strength Softgels
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL
Manufacturer: Topco Associates, LLC
Product type: HUMAN OTC DRUG
SPL set ID: f7ebe482-cb22-4517-8463-3432cf60071d
SPL ID: 4279e770-4465-b250-e063-6394a90a390b
Version: 4
Effective date: 2025-10-31
Source export date: 2026-10-30
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/57469fe40e5b1c0d9604dc7dbc22532ea48e8e53acfb911fc676578d98492f7e/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:29:19

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		Daytime Cold and Flu Max Maximum Strength Softgels	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Topco Associates, LLC	openfda.manufacturer_name
ndc	package	76162-912-24	openfda.package_ndc
ndc	product	76162-912	openfda.product_ndc
ndc11	package	76162091224	derived:openfda.package_ndc
rxcui		1086997	openfda.rxcui
spl id		4279e770-4465-b250-e063-6394a90a390b	id
spl set id		f7ebe482-cb22-4517-8463-3432cf60071d	set_id
unii		9D2RTI9KYH	openfda.unii
unii		04JA59TNSJ	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 is 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.