Aspirin
Rugby 44-227
939fce7e-55df-4dc5-916b-a533448e962f
HUMAN OTC DRUG LABEL
Aug 12, 2025
Rugby Laboratories
DUNS: 079246066
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aspirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (22)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
Rugby**®**
NDC 0536-1232-01
compare to the active ingredient in
Ecotrin® Regular Strength†
regular strength
aspirin
** aspirin 325 mg**
pain reliever(NSAID)
safety coated
for the temporary relief of minor arthritis pain
100 e****nteric coated tablets
actual size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
** SAFETY SEAL UNDER CAP IS BROKEN OR MISSING**
†This product is not manufactured or distributed by Medtech
Products Inc., owner of the registered trademark
Ecotrin® Regular Strength. 50844 REV0122C22712
Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com
Rugby 44-227
INDICATIONS & USAGE SECTION
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
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
STORAGE AND HANDLING SECTION
Other information
-
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
-
see end flap for expiration date and lot number
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391
WARNINGS SECTION
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 are taking a diuretic
-
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
-
you have asthma
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 at 20 weeks or later in 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.
DOSAGE & ADMINISTRATION SECTION
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