FDA.reportPublic FDA data

MIDOL COMPLETE

Manufacturer
R J General Corporation
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:16:23

Label at a glance#

ProductMIDOL COMPLETE
Active ingredientPYRILAMINE MALEATE, ACETAMINOPHEN, CAFFEINE
Label structure8 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

Storage and handling

Store at room temperature.  Avoid temperatures above 25°C (77°F).

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.

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.

Do not use

  • 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.

Directions

  • 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.

OTC - DO NOT USE SECTION

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.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature.  Avoid temperatures above 25°C (77°F).

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) 

PRINCIPAL DISPLAY PANEL - 100 Caplet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol ®
Complete

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine

MAXIMUM STRENGTH
MULTI-SYMPTOM
RELIEF OF

CRAMPS, BLOATING
FATIGUE, BACKACHE
& HEADACHE

50 POUCHES of 2 CAPLETS

image description
image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN7
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD7
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130312843158597GTIN-13: 0312843158597
EAN-13: 0312843158597
GTIN-12: 312843158597
UPC-A: 312843158597
GTIN storage (14 digits): 00312843158597		midol-complete-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70264-012-012022-12-26C16284748780-19d75b9d0-bb1e-f424-e053-dadaa90a57ceMIDOL ® COMPLETE
70264-012-012020-01-31C16284748780-19d75b9d0-bb1e-f424-e053-dadaa90a57ceMIDOL ® COMPLETE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-012-01MIDOL COMPLETE50 in 1 CARTONTABLET507
70264-012-01MIDOL COMPLETE2 in 1 POUCHTABLET27

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
70264-01270264-012-01
0280-8005

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TRIACETINXHX3C3X673IACT
CARNAUBA WAXR12CBM0EIZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
SHELLAC46N107B71OIACT
PYRILAMINE MALEATER35D29L3ZAACTIB
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML

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 MALEATER J General Corporation0c09a178-1a07-4079-b4a6-d1657cb8e7142025-11-17WarningsExact identifier
ndc (package): 70264-012-01
ndc (product): 70264-012
ndc11 (package): 70264001201
spl id: 43c8728c-3666-eb53-e063-6294a90af230
spl set id: 0c09a178-1a07-4079-b4a6-d1657cb8e714
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.