FDA.reportPublic FDA data

MIDOL COMPLETE- acetaminophen, caffeine, and pyrilamine maleate tablet

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:32:20

Label at a glance#

ProductMidol Complete
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure12 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#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

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

Liver warning

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

SPL UNCLASSIFIED SECTION

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

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

  • 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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

PRINCIPAL DISPLAY PANEL- 2 Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol ®
COMPLETE

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

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

2
Caplets

Midol 2ctMidol 2ct

PRINCIPAL DISPLAY PANEL-4 Caplet Pouch Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol ®
COMPLETE

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

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

4
Caplets

Midol 4ctMidol 4ct

PRINCIPAL DISPLAY PANEL-25 Caplet Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol ®
COMPLETE

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

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

25 POUCHES 2 CAPLETS EACH

Midol 25ctMidol 25ct

PRINCIPAL DISPLAY PANEL-30 Caplet Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol ®
COMPLETE

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

BAYER

MULTI-SYMPTOM RELIEF OF

CRAMPS • BLOATING • FATIGUE

HEADACHE • BACKACHE

30 POUCHES 2 CAPLETS EACH
Midol 30ctMidol 30ct

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29485-2802-2Midol Complete1 in 1 BLISTER PACKTABLET16
29485-2802-2Midol Complete2 in 1 POUCHTABLET26
29485-7358-4Midol Complete2 in 1 POUCHTABLET26
29485-7358-4Midol Complete2 in 1 BLISTER PACKTABLET26
29485-7964-2Midol Complete2 in 1 POUCHTABLET26
29485-7964-2Midol Complete25 in 1 BOXTABLET256
29485-7964-3Midol Complete2 in 1 POUCHTABLET26
29485-7964-3Midol Complete30 in 1 BOXTABLET306
29485-7964-4Midol Complete50 in 1 BOXTABLET506
29485-7964-4Midol Complete2 in 1 POUCHTABLET26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-2802MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Legacy NDC, 2 package rows20241101_d20425a4-f074-4154-e053-2995a90ae9fd.zip
29485-7358MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Legacy NDC, 2 package rows20241101_d20425a4-f074-4154-e053-2995a90ae9fd.zip
29485-7964MIDOL COMPLETE (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Current NDC, Legacy NDC, 6 package rows20241101_d20425a4-f074-4154-e053-2995a90ae9fd.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-735829485-7358-4
29485-280229485-2802-2
29485-796429485-7964-2, 29485-7964-3, 29485-7964-4

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 2L06K8R7DQKIACT
CARNAUBA WAXR12CBM0EIZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SHELLAC46N107B71OIACT
TRIACETINXHX3C3X673IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIACETINXHX3C3X673IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CARNAUBA WAXR12CBM0EIZIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SHELLAC46N107B71OIACT
TRIACETINXHX3C3X673IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
ACETAMINOPHEN362O9ITL9DACTIB
CAFFEINE3G6A5W338EACTIB
PYRILAMINE MALEATER35D29L3ZAACTIB
MAGNESIUM STEARATE70097M6I30IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
ndc (package): 29485-2802-2
ndc (package): 29485-7358-4
ndc (package): 29485-7964-2
ndc (package): 29485-7964-3
ndc (package): 29485-7964-4
ndc (product): 29485-7964
ndc (product): 29485-2802
ndc (product): 29485-7358
ndc11 (package): 29485796404
ndc11 (package): 29485796402
ndc11 (package): 29485796403
ndc11 (package): 29485280202
ndc11 (package): 29485735804
spl id: 25b48331-c9a7-a377-e063-6394a90a3ba6
spl set id: d20425a4-f074-4154-e053-2995a90ae9fd

Reported adverse events (FAERS/openFDA)#

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