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 TABLETS
- Manufacturer
- Marlex Pharmaceuticals Inc.
- Effective date
- 2026-10-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-10-30 01:01:41
Label at a glance#
ProductAspirin
Active ingredientASPIRIN
Label structure10 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
Storage and handling
· Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F) · Use by expiration date on package
Contacts and useful links#
Websitewww.marlexpharm.com
www.marlexpharm.com
www.marlexpharm.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Fact
Active ingredient (in each tablet)
Aspirin 81mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever
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 useif 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
· Fever gets worse or lasts more than 3 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:
Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin
Questions?
Adverse Drug Event Call: (888) 582 1953or Email: drugsafety@marlexpharm.com
PRINCIPAL DISPLAY PANEL
Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
NDC 10135-0729-10
NDC 10135-0729-62
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-729-10 | EA - Each | 10135-729 | 671d5b61-cff4-4ea4-9724-3286481f8e95 | 1 | 2025-09-12 |
| 10135-729-62 | EA - Each | 10135-729 | 0aeb499d-1f9b-4794-956c-be29269cedce | 1 | 2021-10-08 |
Products#
Every source-derived product name is available through these pages.
- Aspirin
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- STARCH, CORN
- MICROCRYSTALLINE CELLULOSE
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- TRIETHYL CITRATE
- SILICON DIOXIDE
- TRIACETIN
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- HYPROMELLOSE, UNSPECIFIED
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10135-729 | 10135-729-62, 10135-729-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-08-05 | full-release | 2026-06-01 01:09:23 |
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 |
|---|---|---|---|---|---|---|
| 3ba085f8-2eeb-8958-e063-6394a90a7739 | cc7013ea-cf30-6f59-e053-2a95a90a1148 | 2025-08-05 | Warnings | cc7013ea-cf30-6f59-e053-2a95a90a1148 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.