Maximum strength Day cold and flu and Night 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: Maximum strength Day cold and flu and Night severe cold and flu
Generic name: ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS
Manufacturer: TIME CAP LABORATORIES,INC
Product type: HUMAN OTC DRUG
SPL set ID: fff69901-965c-5372-e053-6394a90a29c2
SPL ID: fff69901-965d-5372-e053-6394a90a29c2
Version: 1
Effective date: 2023-09-18
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 19:43:57

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Maximum strength Day cold and flu and Night severe cold and flu	openfda.brand_name
generic name		ACETAMINOPHE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL TABLETS	openfda.generic_name
manufacturer name		TIME CAP LABORATORIES,INC	openfda.manufacturer_name
ndc	package	49483-726-64	openfda.package_ndc
ndc	product	49483-726	openfda.product_ndc
ndc11	package	49483072664	derived:openfda.package_ndc
rxcui		2549037	openfda.rxcui
rxcui		2560237	openfda.rxcui
rxcui		1110988	openfda.rxcui
spl id		fff69901-965d-5372-e053-6394a90a29c2	id
spl set id		fff69901-965c-5372-e053-6394a90a29c2	set_id

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 4,000 mg 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.