Indications and uses
Temporarily relieves minor aches and pains associated with headache minor arthritis pain common cold menstrual cramps muscular aches backache toothache Temporarily reduces fever.
Aspirin
- Manufacturer
- Certified Safety Manufacturing
- Effective date
- 2017-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:05:27
Label at a glance#
ProductAspirin
Active ingredientAspirin
Label structure10 sections
Dosage and administration
do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings ) drink a full glass of water with each dose Adults and children: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. Children under 12 years: Do not give to children un...
Storage and handling
read all product information before using store at room temperature 59°-86°F (15°-30°C) avoid excessive heat and humidity tamper evident sealed packets do not use any opened or torn packets
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains associated with
- headache
- minor arthritis pain
- common cold
- menstrual cramps
- muscular aches
- backache
- toothache
Temporarily reduces fever.
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
If an allergic reaction occurs, stop use and seek medical help right away.
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 alcohol 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
- if you are taking prescription drugs for gout, diabetes or arthritis
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
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- if ringing in the ears or loss of hearing occurs
- redness or swelling is present in the painful area
- any new symptoms appear
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.
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- drink a full glass of water with each dose
| Adults and children: (12 years and older) | Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor. |
| Children under 12 years: | Do not give to children under 12 years of age. |
Other information
- read all product information before using
- store at room temperature 59°-86°F (15°-30°C)
- avoid excessive heat and humidity
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive ingredients
corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide
Questions or comments?
1-800-xxx-xxxx
PRINCIPAL DISPLAY PANEL - 25 Pouch Box
Tamper evident
packaging:
Do not use if
open or torn.
This package for
households
without children
See New Warnings
Information
Compare to Bayer®
CERTI-ASPIRIN™
325 mg Aspirin (NSAID)*
- Pain Reliever
- Fever Reducer
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- Aspirin
- POWDERED CELLULOSE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE, UNSPECIFIED
- Microcrystalline Cellulose
- Mineral Oil
- POLYETHYLENE GLYCOL, UNSPECIFIED
- Propylene Glycol
- STARCH, CORN
- Titanium Dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48083-654 | 48083-654-66, 48083-654-27, 48083-654-30, 48083-654-33, 48083-654-36, 48083-654-39, 48083-654-41 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Aspirin | R16CO5Y76E | ACTIB |
| POWDERED CELLULOSE | SMD1X3XO9M | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| Microcrystalline Cellulose | OP1R32D61U | IACT |
| Mineral Oil | T5L8T28FGP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| Titanium Dioxide | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| 571355ea-677e-4e6b-87a7-3a26b180e37c | 0accb885-33d3-4c51-9f71-fa2ac4d22245 | 2025-01-31 | Warnings | 0accb885-33d3-4c51-9f71-fa2ac4d22245 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.