ARTRIFIN 24 CAPLETS

Manufacturer
OPMX LLC
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:57:32

Label at a glance#

ProductARTRIFIN 24 CAPLETS
Active ingredientASPIRIN, CAFFEINE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual and menstrual cramps

Dosage and administration

do not use more than directed drink a full glass of water with each dose adults and children 12 years and over take 2 tablets every 6 hours do not take more than 8 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug fatcs

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each caplet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours, wich is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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

  • if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs.
  • Seek medical help right away
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • painful area is red or swollen

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over
    • take 2 tablets every 6 hours
  • do not take more than 8 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

SPL UNCLASSIFIED SECTION

Exclusively distributed by:
OPMX
Chula Vista, CA 91910
PHONE: 619-600-5632

Made for:
inov FARMACEUTIQUE

PRINCIPAL DISPLAY PANEL - 24 CAPLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Reliever/Fever Reducer

Mejora los síntomas

Dolores musculares/Muscular Aches
Dolor de Espalda/Backache
Dolor menor de artitris/Minor pain of Arthritis

24 Caplets

ARTRIFIN 24 CAPLETSARTRIFIN 24 CAPLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN3
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD3
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-105-242025-03-19C16284748780-12cef2736-68ed-d83d-e063-dadaa90ab31fARTRIFIN
69729-105-242025-01-30C16284748780-12cef2736-68ed-d83d-e063-dadaa90ab31fARTRIFIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-105-24ARTRIFIN 24 CAPLETS2 in 1 BOXTABLET23
69729-105-24ARTRIFIN 24 CAPLETS12 in 1 BLISTER PACKTABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-105ARTRIFIN 24 CAPLETS (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [OPMX LLC]3Current NDC, Legacy NDC, 2 package rows20250322_e7f15c2b-a730-b54f-e053-2a95a90a3b3e.zip

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
69729-10569729-105-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
ARTRIFIN 24 CAPLETSACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe7f15c2b-a730-b54f-e053-2a95a90a3b3e2025-03-19WarningsExact identifier
ndc (package): 69729-105-24
ndc (product): 69729-105
ndc11 (package): 69729010524
spl id: 30b6fb57-821e-7ead-e063-6394a90aa651
spl set id: e7f15c2b-a730-b54f-e053-2a95a90a3b3e

Reported adverse events (FAERS/openFDA)#

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