Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg

Manufacturer
WALGREENS CO.
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:50:46

Label at a glance#

ProductAcetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg
Active ingredientACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Label structure10 sections

Indications and uses

for the temporary relief of these symptoms associated with menstural 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 gelcaps with water • repeat every 6 hours as needed • do not exceed 6 gelcaps per day • children under 12 years: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Caffeine 60mg

Pyrilamine maleate 15mg

Purpose

OTC - PURPOSE SECTION

Pain reliever

Diuretic

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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: • hives • blisters • rash • skin reddening • 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

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

Ask a doctor or pharmacist before use if you are
• 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 beacuse 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
• 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, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as 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 gelcaps with water
• repeat every 6 hours as needed
• do not exceed 6 gelcaps per day
• children under 12 years: consult a doctor

Other information

OTHER SAFETY INFORMATION

• each gelcap contains: sodium 3 mg • store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C red #33 aluminum lake, edible black printing ink, ethyl cellulose, FD&C blue #1 aluminum lake, gelatin, glycerin, hydroxypropyl methylcellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, pregelatinized potato starch, purified water, PVPK-30, sorbitol sorbitan solution, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredients in Midol® Complete††

Aspirin Free

• Relieves cramps, bloating, fatigue, headaches & backaches

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com  
1-800-925-4733

©2023 Walgreen Co.

PRODUCT OF UNITED ARAB EMIRATES
PACKAGED AND QUALITY ASSURED IN THE U.S.A.

††Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Menstrual Complete Pain ReliefWalgreens Menstrual Complete Pain Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSN5
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCD5
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSY5

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2310-24Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg24 in 1 PACKAGETABLET245

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2310ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG TABLET [WALGREENS CO.]5Current NDC, Legacy NDC, 1 package rows20250106_982faa74-d498-cd1e-e053-2995a90afa1e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-2310-24EA - Each0363-2310b2e6f9ed-0fe6-4225-b78c-4b1e8634efd112022-06-06

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-23100363-2310-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mgACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MGWALGREENS CO.982faa74-d498-cd1e-e053-2995a90afa1e2024-12-25WarningsExact identifier
ndc (package): 0363-2310-24
ndc (product): 0363-2310
ndc11 (package): 00363231024
spl id: c4826edc-d2bc-4903-9da6-cf25d064ce86
spl set id: 982faa74-d498-cd1e-e053-2995a90afa1e

Reported adverse events (FAERS/openFDA)#

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