Indications and uses
for the temporary relief of minor aches and pains
601 Aspirin 81MG Chewable Orange Tablet 36/BT
- Manufacturer
- Medline Industries, LP
- Effective date
- 2026-08-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-09-15 03:00:59
Label at a glance#
ProductMedline
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 chewable 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 20-25ºC (68-77ºF)
Contacts and useful links#
Websitewww.medline.com
www.medline.com
www.medline.comLabel contents#
Full prescribing information#
Active ingredient (in each chewable tablet)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
for the temporary relief of minor aches and pains
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 becuase 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
- asthma (wheezing)
- shock
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 have ever had an allergic reaction to any other pain reliever/fever reducer
- for at least 7 days after a tonsillectomy or oral surgery unless directed by a doctor
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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -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
- new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition
If pregnant or breast-feeing,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 4 to 8 chewable 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 20-25ºC (68-77ºF)
Inactive ingredients
corn starch, dextrose excipient, FD&C yellow #6 aluminum lake, flavors, saccharin sodium
Questions or comments?
call 1-800-MEDLINE (633-5463)
Monday - Friday, 7 a.m. to 7 p.m. CST
Manfucturing information
**This product is not manufactured or
distributed by Bayer HealthCare LLC,
distributor of Bayer® Chewable Low
Dose Aspirin.
www.medline.com ©2026 Medline
Manufactured for: Medline Industries, LP,
Three Lakes Drive, Northfield, IL 60093 USA
1-800-MEDLINE
Package Label
Products#
Every source-derived product name is available through these pages.
- Medline
- Aspirin
- STARCH, CORN
- DEXTROSE
- FD&C YELLOW NO. 6 ALUMINUM LAKE
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53329-601 | 53329-601-28, 53329-601-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| FD&C YELLOW NO. 6 ALUMINUM LAKE | GYP6Z2JR6Q | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.