Midol

Manufacturer
Select Consumer Group
Effective date
2026-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
weekly-update
Hydrated at
2026-07-17 21:43:19

Label at a glance#

ProductMidol Complete
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure9 sections

Indications and uses

for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle aches fatigue

Dosage and administration

do not take more than the recommended dose adults and children 12 years and older: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: consult a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)Purpose
Acetaminophen 500 mgPain reliever
Caffeine 60 mgDiuretic
Pyrilamine maleate 15 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of these symptoms associated with menstrual periods:

  • cramps
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets 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

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • you may get drowsy
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than the recommended dose
  • adults and children 12 years and older:
    • take 2 caplets with water
    • repeat every 6 hours, as needed
    • do not exceed 6 caplets per day
  • children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-331-4536(Mon-Fri 9AM - 5PM EST) or www.midol.com

label display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18411841

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708118412GTIN-13: 0655708118412
EAN-13: 0655708118412
GTIN-12: 655708118412
UPC-A: 655708118412
GTIN storage (14 digits): 00655708118412
2511841100 - Midol - 1841-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-8005-16EA - Each0280-8005dcbec074-9880-48e9-96d8-049649c185be12018-04-19
0280-8005-24EA - Each0280-8005eaea4dec-a037-41d2-b348-b5491e1f119912018-04-19
0280-8005-40EA - Each0280-80057092f7e0-408c-4e14-a65c-d4ba66cb33dd12016-02-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-184185237-1841-1, 85237-1841-2, 85237-1841-3, 85237-1841-4, 85237-1841-5
0280-8005

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-12-27full-release2026-06-01 01:28:53

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATESelect Consumer Group3ca96ed9-d9af-dbfe-e063-6394a90a29322026-07-03WarningsExact identifier
ndc (package): 85237-1841-1
ndc (package): 85237-1841-2
ndc (package): 85237-1841-4
ndc (package): 85237-1841-3
ndc (package): 85237-1841-5
ndc (product): 85237-1841
ndc11 (package): 85237184104
ndc11 (package): 85237184101
ndc11 (package): 85237184105
ndc11 (package): 85237184103
ndc11 (package): 85237184102
spl id: 55bc3945-3864-e797-e063-6394a90a2f87
spl set id: 3ca96ed9-d9af-dbfe-e063-6394a90a2932
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEBayer HealthCare LLC.ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a3242025-04-10WarningsExact identifier
ndc (product): 0280-8005

Reported adverse events (FAERS/openFDA)#

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