Midol Complete Gelcaps

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: Midol Complete Gelcaps
Generic name: MIDOL COMPLETE
Manufacturer: Bayer HealthCare LLC
Product type: HUMAN OTC DRUG
SPL set ID: 0a4477ce-0a02-197d-e054-00144ff88e88
SPL ID: 4526be49-a733-1db7-e063-6394a90a1937
Version: 6
Effective date: 2025-12-04
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:40:21

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		M027	openfda.application_number
brand name		Midol Complete Gelcaps	openfda.brand_name
generic name		MIDOL COMPLETE	openfda.generic_name
manufacturer name		Bayer HealthCare LLC	openfda.manufacturer_name
ndc	package	0280-8015-24	openfda.package_ndc
ndc	product	0280-8015	openfda.product_ndc
ndc11	package	00280801524	derived:openfda.package_ndc
rxcui		1597298	openfda.rxcui
spl id		4526be49-a733-1db7-e063-6394a90a1937	id
spl set id		0a4477ce-0a02-197d-e054-00144ff88e88	set_id
unii		3G6A5W338E	openfda.unii
unii		R35D29L3ZA	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 6 gelcaps in 24 hours, which is the maximum daily amount for this product · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.