Leader 44-183

Leader 44-183
SPL v13
SPL
SPL Set ID e5f68c1a-21f3-45a1-861f-229a95b3721c
Route
ORAL
Published
Effective Date 2026-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Anhydrous Citric Acid Starch, Corn Sodium Phosphate, Dibasic, Anhydrous Hydrogenated Cottonseed Oil Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Propylene Glycol Shellac Dimethicone 410 Silicon Dioxide Sodium Lauryl Sulfate Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;183 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1990-03-30 Until 2027-07-31

Description

Buffered aspirin equal to 325 mg aspirin (NSAID)* (buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer 


Medication Information

Purpose

Pain reliever/fever reducer 

Description

Buffered aspirin equal to 325 mg aspirin (NSAID)* (buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) *nonsteroidal anti-inflammatory drug

Uses
  • temporarily relieves minor aches and pains associated with:
    • toothache
    • minor pain of arthritis
    • backache
    • the common cold
    • headache
    • muscular aches
    • premenstrual & menstrual cramps
  • 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:

  • shock
  • hives
  • asthma (wheezing)
  • facial swelling

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 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
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
  • each tablet contains: calcium 35 mg and magnesium 45 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredient 

Buffered aspirin equal to 325 mg aspirin (NSAID)*

(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Leader

NDC 70000-0147-1

Buffered Aspirin

Tri-Buffered Aspirin, 325 mg Tablets

Pain Reliever / Fever Reducer (NSAID)

130

COATED

TABLETS

ACTUAL SIZE

COMPARE TO

BUFFERIN®

active ingredient

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 5285770          REV. 4/22

†This product is not manufactured or distributed by Genomma Lab

USA, Inc., owner of the registered trademark Bufferin®.

50844     REV0122B18330

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

All LEADERTM Brand

Products Have A

100%

Money Back

Guarantee

© 2022 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,

the Cardinal Health LOGO, LEADER, and the Leader LOGO are

trademarks or registered trademarks of Cardinal Health.

Leader 44-183
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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses
  • temporarily relieves minor aches and pains associated with:
    • toothache
    • minor pain of arthritis
    • backache
    • the common cold
    • headache
    • muscular aches
    • premenstrual & menstrual cramps
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer 

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:

  • shock
  • hives
  • asthma (wheezing)
  • facial swelling

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • take more or for a longer time than directed
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 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
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)
  • each tablet contains: calcium 35 mg and magnesium 45 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Active Ingredient  (Active ingredient )

Buffered aspirin equal to 325 mg aspirin (NSAID)*

(buffered with calcium carbonate, magnesium carbonate, and magnesium oxide)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, corn starch, dibasic sodium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac wax, simethicone, sodium lauryl sulfate, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

Leader

NDC 70000-0147-1

Buffered Aspirin

Tri-Buffered Aspirin, 325 mg Tablets

Pain Reliever / Fever Reducer (NSAID)

130

COATED

TABLETS

ACTUAL SIZE

COMPARE TO

BUFFERIN®

active ingredient

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 5285770          REV. 4/22

†This product is not manufactured or distributed by Genomma Lab

USA, Inc., owner of the registered trademark Bufferin®.

50844     REV0122B18330

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

All LEADERTM Brand

Products Have A

100%

Money Back

Guarantee

© 2022 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,

the Cardinal Health LOGO, LEADER, and the Leader LOGO are

trademarks or registered trademarks of Cardinal Health.

Leader 44-183
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 have asthma
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
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:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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.

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

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

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