Indications and uses
for the temporary relief of minor aches and pains or as recommended by your doctor
Aspirin
- Manufacturer
- KEM Pharma LLC | LNK International, Inc.
- Effective date
- 2025-04-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 16
- Source
- full-release
- Hydrated at
- 2026-06-01 00:59:00
Label at a glance#
ProductAspirin
Active ingredientASPIRIN
Label structure8 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: ask a doctor
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
for the temporary relief of minor aches and pains or as recommended by your doctor
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:
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- take more or for a longer time than directed
- have had stomach ulcers or bleeding problems
- have 3 or more alcoholic drinks every day while using this product
- take a blood thinning (anticoagulant) or steroid drug
- are age 60 or older
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 have asthma
- you are taking a diuretic
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
- you experience any of the following signs of stomach bleeding:
- vomit blood
- have bloody or black stools
- feel faint
- have stomach pain that does not get better
- an allergic reaction occurs. Seek medical help right away.
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
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 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 (1-800-222-1222) 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: ask a doctor
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
Low Dose
Aspirin 81 mg
Pain Reliever (NSAID)
Enteric Coated Yellow Round Tablet
Actual Size
Safety Coated
Aspirin Regimen
Enteric Coated
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
CLOSE TIGHTLY
TO OPEN PUSH DOWN & TURN
This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
50844 ORG091560032
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60503-600-32 | Aspirin | 120 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 120 | 16 | |
| 60503-600-32 | Aspirin | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 16 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 5 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 5 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 5 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 5 |
Products#
Every source-derived product name is available through these pages.
- Aspirin
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID
- MICROCRYSTALLINE CELLULOSE
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- SHELLAC
- SILICON DIOXIDE
- DIMETHICONE
- WATER
- SODIUM BICARBONATE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60503-600 | 60503-600-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | FILM, SOLUBLE / ORAL | 2 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | PASTE / DENTAL | NA | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, DELAYED RELEASE / ORAL | 8 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | SOLUTION / ORAL | ADJ PH | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, CHEWABLE / ORAL | 4 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / SUBLINGUAL | 6 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | SUSPENSION / ORAL | 71 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 3059 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET / BUCCAL | 42 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 3219 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INSERT / VAGINAL | 129 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | POWDER, FOR SUSPENSION / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, FILM COATED / ORAL | 120 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 147 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EXTENDED RELEASE / ORAL | 81 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | GUM, CHEWING / BUCCAL | 240 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / VAGINAL | 12 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, EXTENDED RELEASE / ORAL | 129 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, CHEWABLE / ORAL | 0.41 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE, DENTIFRICE / DENTAL | 1.4 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SUSPENSION, EXTENDED RELEASE / ORAL | 0.08 mg/1ml | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | LOZENGE / ORAL | 100 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | JELLY / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / BUCCAL | 1 mg |
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 |
|---|---|---|---|---|---|---|
| b59185cd-91c5-4212-9af9-fbe6bda1157c | ecdf88f6-6f4a-4f65-bb22-df2311360ad3 | 2026-04-02 | Warnings | ecdf88f6-6f4a-4f65-bb22-df2311360ad3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.