Indications and uses
Temporarily relieves minor aches and pains. For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
Aspirin 81mg Enteric Coated Tablets
- Manufacturer
- Marlex Pharmaceuticals Inc
- Effective date
- 2021-09-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:42:30
Label at a glance#
ProductAspirin 81 mg Enteric Coated
Active ingredientASPIRIN
Label structure9 sections
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 not to exceed 48 tablets in 24 hours unless directed by a doctor Children under 12 years: consult a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
ASPIRIN 81MG TABLETS
Marlex Pharmaceuticals, Inc.
----------
Purpose
| Drug Fact | |
| Active ingredient (in each tablet) | Purpose |
| Aspirin 81mg (NSAID*)…………………………………………Pain Reliever
*nonsteroidal anti-inflammatory drug | |
Aspirin 81 mg Tablets
Uses
- Temporarily relieves minor aches and pains.
- For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
Warnings
Reye’s syndrome: 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: Aspirin may cause a severe allergic reaction, which may include:
- Hives
- Facial Swelling
- Shock
- Asthma (wheezing)
Stomach bleeding warning: 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
if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if
- 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
- You have asthma
- You have not been drinking fluids
- You have lost a lot of fluid due to vomiting or diarrhea
Ask a doctor or a pharmacist before use if you are
- 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
- 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
- Pain gets worse or lasts more than 10 days
- Redness or swelling is present in the painful area
- Any new symptoms appear
- Ringing in the ears or a loss of hearing occurs
If pregnant or breast-feeding
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 problem in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
- Drink a full glass of water with each dose
- Adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
- Children under 12 years: consult a doctor
Other Information:
- Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
- Use by expiration date on package
Inactive Ingredients:
Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6
Questions?
Adverse Drug Event Call: (800) 222-1222
Manufactured for & Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev: 12/19 HP
PRINCIPAL DISPLAY PANEL
ASPIRIN
81mg
120 Tablets
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10135-689-62 | 2023-01-30 | C162847 | 48780-1 | f386c649-e756-0266-e053-dadaa90a7c1a | Aspirin 81mg Enteric Coated Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-689-62 | Aspirin 81 mg Enteric Coated | 120 in 1 BOTTLE | TABLET | 120 | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-689-62 | EA - Each | 10135-689 | 2a056e1e-dc8f-4134-8550-a390f7c37f66 | 1 | 2020-04-20 |
Products#
Every source-derived product name is available through these pages.
- Aspirin 81 mg Enteric Coated
- Aspirin
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
- STARCH, CORN
- STEARIC ACID
- SILICON DIOXIDE
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- TRIETHYL CITRATE
- TALC
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10135-689 | 10135-689-62 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ccb224b8-342b-19f3-e053-2a95a90a7d91 | e35ebda4-aff9-4870-81e2-85b85e5c4db1 | 2021-09-23 | Warnings | ccb224b8-342b-19f3-e053-2a95a90a7d91 e35ebda4-aff9-4870-81e2-85b85e5c4db1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.