Rugby 44-227

Rugby 44-227
SPL v13
SPL
SPL Set ID 939fce7e-55df-4dc5-916b-a533448e962f
Route
ORAL
Published
Effective Date 2026-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Ferrosoferric Oxide Powdered Cellulose Silicon Dioxide Starch, Corn D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Propylene Glycol Shellac Dimethicone Water Sodium Alginate Sodium Bicarbonate Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 44;227 Shape: round Color: orange Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-01

Description

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever



Description

Aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

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
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 while symptoms last
  • do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor
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

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 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?

1-800-426-9391

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

  

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

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.

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • diabetes
  • arthritis 
  • gout


Structured Label Content

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
Purpose

Pain reliever



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
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 while symptoms last
  • do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor
Do Not Use (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

Other Information (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 Ingredients (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? (Questions or comments?)

1-800-426-9391

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

  

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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, (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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • diabetes
  • arthritis 
  • gout


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)