MAXIMUM STRENGTH DAYTIME NIGHTTIME 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 DAYTIME NIGHTTIME COLD AND FLU
Generic name: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL
Manufacturer: CVS Pharmacy, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: c17b8f17-95f6-37e4-e053-2995a90a411a
SPL ID: 4de96330-ff57-5acf-e063-6394a90a8375
Version: 4
Effective date: 2026-03-26
Source export date: 2026-10-30
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/2026-10-30/023bc8d8aae5addb7530087bbbdb169b3ccbf36764f15b8ca67db07e1e5aea8b/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:09:16

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU	openfda.brand_name
generic name		ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		CVS Pharmacy, Inc.	openfda.manufacturer_name
ndc	package	69842-094-16	openfda.package_ndc
ndc	package	69842-451-24	openfda.package_ndc
ndc	package	69842-382-08	openfda.package_ndc
ndc	product	69842-451	openfda.product_ndc
ndc11	package	69842038208	derived:openfda.package_ndc
ndc11	package	69842009416	derived:openfda.package_ndc
ndc11	package	69842045124	derived:openfda.package_ndc
rxcui		2634364	openfda.rxcui
rxcui		1297288	openfda.rxcui
rxcui		1656815	openfda.rxcui
spl id		4de96330-ff57-5acf-e063-6394a90a8375	id
spl set id		c17b8f17-95f6-37e4-e053-2995a90a411a	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 12 softgels 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.