Indications and uses
temporarily relieves minor aches and pains due to: headache menstrual pain a cold toothache muscle pain minor pain of arthritis or as recommended by your doctor
Aspirin
- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Effective date
- 2022-03-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:41:55
Label at a glance#
ProductAspirin Regular Strength
Active ingredientASPIRIN
Label structure9 sections
Dosage and administration
do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor children under 12 years: do not use unless directed by a doctor
Storage and handling
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Contacts and useful links#
Websitewww.rugbylaboratories.com
www.rugbylaboratories.com
www.rugbylaboratories.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- headache
- menstrual pain
- a cold
- toothache
- muscle pain
- 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:
- facial swelling
- hives
- shock
- asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- diabetes
- arthritis
- gout
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:
- vomit blood
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
- ringing in the ears or a loss of hearing occurs
- new symptoms occur
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
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.
Directions
- do not take more than directed
- drink a full glass of water with each dose
- adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor
- children under 12 years: do not use unless directed by a doctor
Other information
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
Call 1-800-645-2158
Rev. 05-21 R-17
50844 REV0421A22712
Talk to your doctor or other healthcare provider before using this product for your heart.
Distributed by: RUGBY® LABORATORIES, Livonia, MI 48152
www.rugbylaboratories.com
Principal display panel
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-1232-01 | EA - Each | 0536-1232 | 19667f61-f8a3-4dc5-ae98-d510ce699838 | 1 | 2019-08-06 |
Products#
Every source-derived product name is available through these pages.
- Aspirin Regular Strength
- Aspirin
- FERROSOFERRIC OXIDE
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- Polyvinyl Acetate Phthalate
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM ALGINATE
- SODIUM BICARBONATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
- DIMETHICONE
- WATER
- POWDERED CELLULOSE
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0615-8324 | 0615-8324-39 |
| 0536-1232 |
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 |
|---|---|---|---|---|---|---|
| Aspirin Regular Strength | ASPIRIN | Rugby Laboratories | 939fce7e-55df-4dc5-916b-a533448e962f | 2026-05-08 | Warnings | 0536-1232 |
| cfc90580-5962-48ea-99a0-1dee1d3ea68e | 6b43ffdd-c9ba-4587-9928-532e11e56c75 | 2022-03-31 | Warnings | cfc90580-5962-48ea-99a0-1dee1d3ea68e 6b43ffdd-c9ba-4587-9928-532e11e56c75 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.