Midol Complete

Manufacturer
Bayer HealthCare LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:19:37

Label at a glance#

ProductMidol Complete Gelcaps
Active ingredientCAFFEINE, PYRILAMINE MALEATE, ACETAMINOPHEN
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gelcap) Purpose

Acetaminophen 500 mg..............................………………….Pain reliever

Caffeine 60 mg……….…………………………………….……..….Diuretic

Pyrilamine maleate 15 mg……………………………………Antihistamine

INDICATIONS & USAGE SECTION

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

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION


Ask a doctor before use if you have
· liver disease
· glaucoma
· difficulty in urination due to enlargement of the prostate gland
· a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are
· taking the blood thinning drug warfarin
· taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product
· 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if
· 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.

DOSAGE & ADMINISTRATION SECTION

Directions

· do not take more than the recommended dose

· adults and children 12 years and older:

· take 2 gelcaps with water

· repeat every 6 hours, as needed

· do not exceed 6 gelcaps per day

· children under 12 years: consult a doctor

OTHER SAFETY INFORMATION

Other information

· store at room temperature

· avoid excessive heat 104°F (40°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

OTC - QUESTIONS SECTION

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol Complete Gelcaps 24ct CartonMidol Complete Gelcaps 24ct Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN6
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD6
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY6

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-130312843172531GTIN-13: 0312843172531
EAN-13: 0312843172531
GTIN-12: 312843172531
UPC-A: 312843172531
GTIN storage (14 digits): 00312843172531
Midol Complete Gelcaps 24ct Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-8015-24Midol CompleteGelcaps3 in 1 CARTONTABLET, COATED36
0280-8015-24Midol CompleteGelcaps24 in 1 BLISTER PACKTABLET, COATED246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-8015-24EA - Each0280-801537438ee9-425a-4c47-8850-790a39c0ba1312018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
CAFFEINEACTIVE INGREDIENT3G6A5W338E1
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZA1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
CAFFEINEACTIVE MOIETY3G6A5W338E1
PYRILAMINEACTIVE MOIETYHPE317O9TL1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-80150280-8015-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
2 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol Complete GelcapsMIDOL COMPLETEBayer HealthCare LLC0a4477ce-0a02-197d-e054-00144ff88e882025-12-04WarningsExact identifier
ndc (package): 0280-8015-24
ndc (product): 0280-8015
ndc11 (package): 00280801524
spl id: 4526be49-a733-1db7-e063-6394a90a1937
spl set id: 0a4477ce-0a02-197d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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