Mejoral

Manufacturer
OPMX LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:24

Label at a glance#

ProductMejoral
Active ingredientACETAMINOPHEN, CAFFEINE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pain due to: headache muscular aches

Dosage and administration

do not exceed recommended dosage adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Caffeine 65 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pain due to:
  • headache
  • muscular aches

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
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Caffeine warning

SPL UNCLASSIFIED SECTION

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have liver disease

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • any new symptoms occur
  • symptoms do not get better or worsen
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 exceed recommended dosage
  • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 6 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C blue #1, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, polyvinylpyrrolidone, stearic acid, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-154-24

Mejoral

500 mg

Acetaminophen 500 mg

Caffeine 65 mg

Headache or Migraines/Dolor de cabeza o migraña

Muscular Aches/ Dolores Musculares

24 Caplets

MejoralMejoral

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN2
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD2
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

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

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
69729-154-242025-03-19C16284748780-12cef2736-763c-d83d-e063-dadaa90ab31fMejoral
69729-154-242025-01-30C16284748780-12cef2736-763c-d83d-e063-dadaa90ab31fMejoral

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-154-24Mejoral2 in 1 CARTONTABLET, FILM COATED22
69729-154-24Mejoral12 in 1 BLISTER PACKTABLET, FILM COATED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-154MEJORAL (ACETAMINOPHEN, CAFFEINE) TABLET, FILM COATED [OPMX LLC]2Current NDC, 2 package rows20250322_0bccf571-fcb9-2dd5-e063-6294a90a5f16.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
69729-15469729-154-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
MejoralACETAMINOPHEN, CAFFEINEOPMX LLC0bccf571-fcb9-2dd5-e063-6294a90a5f162025-03-19WarningsExact identifier
ndc (package): 69729-154-24
ndc (product): 69729-154
ndc11 (package): 69729015424
spl id: 30b68c1e-b60f-4e36-e063-6294a90a77dc
spl set id: 0bccf571-fcb9-2dd5-e063-6294a90a5f16

Reported adverse events (FAERS/openFDA)#

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