Indications and uses
for the temporary relief of minor aches and pains
aspirin
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2019-06-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:21:03
Label at a glance#
Productaspirin
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 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Storage and handling
store at 20-25°C (68-77°F)
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
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 have ever had an allergic reaction to any other pain reliever/fever reducer
- for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
Ask a doctor before use if
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- 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
- 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
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or loss of hearing occurs
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 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. (1-800-222-1222)
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: consult a doctor
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients
corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium
Questions or comments?
1-800-616-2471
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: aspirin
GENERIC: Aspirin
DOSAGE: TABLET, CHEWABLE
ADMINSTRATION: ORAL
NDC: 70518-0699-0
NDC: 70518-0699-1
COLOR: orange
FLAVOR: ORANGE
SHAPE: ROUND
SCORE: No score
SIZE: 8 mm
IMPRINT: L467
PACKAGING: 30 in 1 BOTTLE, PLASTIC
PACKAGING: 36 in 1 BOTTLE
ACTIVE INGREDIENT(S):
- ASPIRIN 81mg in 1
INACTIVE INGREDIENT(S):
- FD&C YELLOW NO. 6
- SACCHARIN SODIUM
- STARCH, CORN
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-4040-73 | EA - Each | 0904-4040 | bb5cc8ec-5b24-4182-ad88-2e3f62517679 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- aspirin
- FD&C YELLOW NO. 6
- SACCHARIN SODIUM
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70518-0699 | 70518-0699-0, 70518-0699-1 |
| 0904-4040 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
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 |
|---|---|---|---|---|---|---|
| aspirin | ASPIRIN | Major Pharmaceuticals | 58684138-04d1-44a4-bc52-c5b85d93d7a6 | 2024-08-23 | Warnings | 0904-4040 |
| a49b5944-a324-bfea-e053-2a95a90a2609 | ef375011-0524-45f8-b7c2-8a77898e8efe | 2020-05-01 | Warnings | ef375011-0524-45f8-b7c2-8a77898e8efe |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.