Indications and uses
temporarily relieves minor aches and pains other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
Aspirin
- Manufacturer
- Western Family Foods, Inc.
- Effective date
- 2018-12-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:38:36
Label at a glance#
ProductAspirin Enteric Coated
Active ingredientASPIRIN
Label structure10 sections
Dosage and administration
do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age 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: consult a doctor
Contacts and useful links#
Websitewww.westernfamily.com
www.westernfamily.com
www.westernfamily.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
- other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
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
- asthma(wheezing)
- shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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
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:
- anticoagulation (thinning of the blood)
- 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 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.
Directions
- do not exceed recommended dosage
- drink a full glass of water with each dose
- adults and children 12 years of age 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: consult a doctor
Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- do not use if imprinted safety seal under cap is broken or missing
- †This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg
Inactive ingredients
*acetylated monoglycerides, *anhydrous lactose, *carnauba wax, colloidal silicon dioxide,*corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron
oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, povidone, pregelatinized starch, *propylene glycol, *simethicone, silicon dioxide, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, and triethyl citrate. *May also contain.
Questions or comments?
Call us at 503-639-6300, Mon- Fri 9 a.m to 5 p.m. PST
Principal Display Panel
Compare to BAYER® 81 mg active ingredient †
SEE NEW WARNINGS INFORMATION
Enteric Coated Aspirin 81 mg
adult low strength
Pain reliever (NSAID)*
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Proudly Distributed by Western Family Foods, Inc
P.O Box 4057, Portland, OR 97208 USA
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 2 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 2 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 2 | |
| DIACETYLATED MONOGLYCERIDES | INACTIVE INGREDIENT | 5Z17386USF | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) | INACTIVE INGREDIENT | 87Y6436BKR | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | 2 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Enteric Coated
- Aspirin
- DIACETYLATED MONOGLYCERIDES
- ANHYDROUS LACTOSE
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- HYPROMELLOSES
- HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
- FERRIC OXIDE YELLOW
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- POLYETHYLENE GLYCOL 400
- POLYSORBATE 80
- POVIDONE
- STARCH, CORN
- PROPYLENE GLYCOL
- DIMETHICONE
- SILICON DIOXIDE
- SODIUM BICARBONATE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55312-440 | 55312-440-12 |
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 |
|---|---|---|---|---|---|---|
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, FILM COATED / ORAL | 2906 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL | ADJ PH | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / ORAL | 1 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE / ORAL | 349 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAMUSCULAR | 5 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SPRAY / TOPICAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | SUSPENSION / ORAL | 71 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / OPHTHALMIC | 46 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 25 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, FILM COATED / ORAL | 15.12 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / SUBLINGUAL | 1 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAMUSCULAR | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL | ADJ PH | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 10 mg | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | 74G4R6TH13 | CAPSULE, DELAYED RELEASE / ORAL | 79 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | INSERT / VAGINAL | 15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUPPOSITORY / VAGINAL | 30 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAVENOUS | ADJ PH | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | GEL / TOPICAL | 0.05 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| TRIETHYL CITRATE | TRIETHYL CITRATE | 8Z96QXD6UM | CAPSULE, COATED / ORAL | 7 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION, SOLUTION / INTRAVENOUS | 24186 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET, DELAYED RELEASE / ORAL | 1083 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EXTENDED RELEASE / ORAL | 81 mg | ||
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | 74G4R6TH13 | CAPSULE / ORAL | 40 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LIQUID / TOPICAL | 1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAMUSCULAR | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 04cd4e58-c7ca-48fc-9201-987164e7cf32 | 7ea6a989-e97d-4374-892b-ecb3e81fc50b | 2018-12-28 | Warnings | 04cd4e58-c7ca-48fc-9201-987164e7cf32 7ea6a989-e97d-4374-892b-ecb3e81fc50b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.