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
- Manufacturer
- Freds Inc
- Effective date
- 2018-12-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:43:34
Label at a glance#
ProductAspirin Enteric Coated
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 of age : do not use unless directed by a doctor
Storage and handling
store at controlled room temperature 15º-30ºC (59º-86ºF)
Contacts and useful links#
Websitewww.fredsinc.com
www.fredsinc.com
www.fredsinc.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 81 mg (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:
- facial swelling
- hives
- 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 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
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:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- allergic reaction occurs
- 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
- any new symptoms appear
- redness or swelling is present in the painful area
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 SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING THE 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 of age: do not use unless directed by a doctor
Other information
- store at controlled room temperature 15º-30ºC (59º-86ºF)
Inactive ingredients
anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate
Questions or comments?
Call toll free:1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Aspirin 81 mg
Adult Low Strength Enteric Coated
Aspirin Regimen
Pain Reliever (NSAID)*
Delayed Release
tablets
Compare to the active ingredient in St. Joseph® Aspirin**
**This product is not manufactured or distributed by ILEX Consumer Products Group, owner of the registered trademark ST. JOSEPH® 81 mg.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 1 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Enteric Coated
- Aspirin
- ANHYDROUS LACTOSE
- CARNAUBA WAX
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- FERRIC OXIDE YELLOW
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- CELLULOSE, MICROCRYSTALLINE
- POLYSORBATE 80
- DIMETHICONE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- TALC
- TRIETHYL CITRATE
- ALUMINUM OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55315-103 | 55315-103-18 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ENDOTRACHEAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, FILM COATED / ORAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRATHECAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, FOAM / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / OPHTHALMIC | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRALESIONAL | 4 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, DELAYED RELEASE / ORAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY, METERED / NASAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SOLUTION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / PERIODONTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GEL / VAGINAL | 0.2 %w/w | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / BUCCAL | 48 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED / ORAL | 0.04 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, COATED / ORAL | 207.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRADERMAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / TOPICAL | 0.98 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 0.35 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAOCULAR | ADJ PH | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | ELIXIR / ORAL | 12.5 mg/5ml | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | TABLET, DELAYED RELEASE / ORAL | 120 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | POWDER / ORAL | 5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 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 |
|---|---|---|---|---|---|---|
| 9e04d5a6-5966-48aa-bbf8-cf91c5528f65 | b48fa0fe-78c1-4932-bae1-bc41199bcf4c | 2018-12-11 | Warnings | 9e04d5a6-5966-48aa-bbf8-cf91c5528f65 b48fa0fe-78c1-4932-bae1-bc41199bcf4c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.