Indications and uses
for the temporary relief of minor aches and pains due to: headache toothache muscle pain minor arthritis pain menstrual pain colds or as recommended by a doctor
Aspirin
- Manufacturer
- Allegiant Health
- Effective date
- 2019-12-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:20:54
Label at a glance#
ProductAspirin Enteric Coated
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 1 to 2 tablets every 4 hours while symptoms last do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
for the temporary relief of minor aches and pains due to:
- headache
- toothache
- muscle pain
- minor arthritis pain
- menstrual pain
- colds
- or as recommended by a 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, 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 aspirinor 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 diabetes, gout, or 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
- an allergic reaction occurs.
Seek medical help right away.
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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 delivery.
Keep out of reach of children
In case of overdose, get medical help or contact a PoisonControlCenter (1-800-222-1222) right away.
Directions
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: consult a doctor
Inactive Ingredients
corn starch, croscarmellose sodium, D&C Yellow 10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate
Package/Label Principal Display Panel
Products#
Every source-derived product name is available through these pages.
- Aspirin Enteric Coated
- Aspirin 325 mg
- ASPIRIN
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- ALUMINUM OXIDE
- POLYSORBATE 80
- FD&C YELLOW NO. 6
- DIMETHICONE
- TRIETHYL CITRATE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- HYPROMELLOSES
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69168-400 | 69168-400-30, 69168-400-17 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| aacad958-9ade-44c9-9f58-77521d876ff6 | 3d426f2d-e8bc-47c5-8a10-e15a886c2651 | 2019-12-12 | Warnings | aacad958-9ade-44c9-9f58-77521d876ff6 3d426f2d-e8bc-47c5-8a10-e15a886c2651 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.