Indications and uses
for the temporary relief of minor aches and pains due to: headache muscle pain toothache menstrual pain colds minor pain of arthritis or as recommended by your doctor
enteric coated aspirin
- Manufacturer
- Strategic Sourcing Services LLC
- Effective date
- 2023-10-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:22:57
Label at a glance#
Productenteric coated aspirin Regular Strength
Active ingredientASPIRIN
Label structure9 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: ask a doctor
Storage and handling
store between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
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
- muscle pain
- toothache
- menstrual pain
- colds
- minor pain of arthritis
- 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
- 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 more alcoholic drinks every day while using this product
- take more or for a longer time than directed
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- diabetes
- gout
- 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 for more than 10 days
- redness or swelling is present
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- ringing in the ears or loss of hearing occurs
These could be signs of a serious condition
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 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: ask a doctor
Other information
- store between 20-25°C (68-77°F) in a dry place
- retain carton for complete product information and warnings
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
PRINCIPAL DISPLAY PANEL
sunmark®
COMPARE TO ECOTIN® REGULAR STRENGTH ACTIVE INGREDIENT†
NDC 70677-0071-1
enteric coated aspirin
Regular Strength
Pain Reliever (NSAID)
ASPIRIN REGIMEN**
SAFETY COATED
125 TABLETS - 325 MG EACH
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70677-0071-1 | EA - Each | 70677-0071 | 0c08a019-0439-4d9a-b8db-a3c234396b9e | 1 | 2021-02-05 |
Products#
Every source-derived product name is available through these pages.
- enteric coated aspirin Regular Strength
- Aspirin
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10
- ALUMINUM OXIDE
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
- CELLULOSE, MICROCRYSTALLINE
- MINERAL OIL
- POLYSORBATE 80
- DIMETHICONE
- SODIUM HYDROXIDE
- SODIUM LAURYL SULFATE
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70677-0071 | 70677-0071-1 |
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 |
|---|---|---|---|---|---|---|
| 08f39ac5-9535-bc11-e063-6394a90ad71e | 89157243-c14d-03cd-e053-2a95a90a0c8c | 2023-10-30 | Warnings | 08f39ac5-9535-bc11-e063-6394a90ad71e 89157243-c14d-03cd-e053-2a95a90a0c8c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.