CARDIASPIRIN PROTECT

Manufacturer
OPMX LLC | Elysium Pharmaceuticals Ltd
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-08-21 02:01:30

Label at a glance#

ProductCARDIASPIRIN PROTECT
Active ingredientASPIRIN
Label structure8 sections

Indications and uses

ftemporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms lasts. do not take more than 48 tablets in 24 hours unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Active ingredient (in each tablet)Purpose
Aspirin 81mg (NSAID)*Pain reliever

*nonsteroidal ant-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • ftemporarily relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.

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)

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

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR SECTION

  • you have asthma
  • 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 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
  • under a doctor's care for any serious condition
  • taking any other drug

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.
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

These could be sing of a serious condition.

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

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 sings or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
adults and children 12 years and over:
  • take 4 to 8 tablets every 4 hours while symptoms lasts.
  • do not take more than 48 tablets in 24 hours unless directed by a doctor

children under 12 years:

  • ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 15-30 °C (59-86 °F)
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Anhydrous Lactose, Carnuba Wax, Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Microcrystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

call toll free Call (619) 600-5632

Monday through Friday 9AM – 5PM EST

Cardiaspirin Protect Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-104-12

Adult Low Doses

CARDIASPIRIN PROTECT

Aspirin 81mg/ Pain Reliever (NSAID)

Safety Coated

Aspirin Regimen

120 tablets

BOXBOX

BOTTLEBOTTLE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeopmx.us/Cardiaspirin Protect w120 tablets BOTTLE.jpg, Cardiaspirin Protect w120 BOX.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-104-122025-07-29C16284748780-13b156c62-2aad-fb37-e063-e6dba90a4e07CARDIASPIRIN PROTECT
69729-104-122025-07-29C16284748780-13b156c62-2aad-fb37-e063-e6dba90a4e07CARDIASPIRIN PROTECT
69729-104-122025-07-29C16284748780-13b156c62-2aad-fb37-e063-e6dba90a4e07CARDIASPIRIN PROTECT

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-10469729-104-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-23daily-update2026-07-29 05:10:14
22024-12-03full-release2026-06-01 00:40:18

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
CARDIASPIRIN PROTECTASPIRINOPMX LLC03774690-662b-1c30-e063-6294a90a34882026-08-19WarningsExact identifier
ndc (package): 69729-104-12
ndc (product): 69729-104
ndc11 (package): 69729010412
spl id: 596aa89c-cc19-7c35-e063-6394a90a5f5c
spl set id: 03774690-662b-1c30-e063-6294a90a3488

Reported adverse events (FAERS/openFDA)#

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