Leader 44-413

Leader 44-413
SPL v16
SPL
SPL Set ID 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (500 mg) Caffeine (32.5 mg)
Inactive Ingredients
Starch, Corn Hypromellose, Unspecified Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: 44;413 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-04-12 Until 2021-08-08

Description

Aspirin 500 mg (NSAID)* Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever

Pain reliever aid

Description

Aspirin 500 mg (NSAID)* Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of

  • backache pain
  • muscle aches and pains
  • minor aches and pains of arthritis
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
  • shock
  • facial swelling
  • asthma (wheezing)

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

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product
  • have had stomach ulcers or bleeding problems
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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 caplets every 6 hours, not to exceed 8 caplets in 24 hours
  • 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

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER

NDC 70000-0127-2

Extra Strength

Back & Body

Aspirin (NSAID), 500 mg | Caffeine, 32.5 mg

Pain Reliever | Pain Reliever Aid

Relieves Backaches

and Muscle Aches & Pains

COMPARE TO

BAYER® BACK & BODY


active ingredients

100% Money Back Guarantee

100 CAPLETS

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

Bayer AG, owner of the registered trademark Bayer®

Back & Body.       

50844            REV0222B41312

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com   1-800-200-6313

Essential to Care™ since 1979

 All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

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

the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the

Leader LOGO are trademarks or registered trademarks of

Cardinal Health. All other marks are the property of their

respective owners.

Leader 44-413
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
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
    • have bloody or black stools
    • feel faint
    • 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.

Active Ingredients (in Each Caplet)

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses

for the temporary relief of

  • backache pain
  • muscle aches and pains
  • minor aches and pains of arthritis
Purpose

Pain reliever

Pain reliever aid

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
  • shock
  • facial swelling
  • asthma (wheezing)

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

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product
  • have had stomach ulcers or bleeding problems
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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 caplets every 6 hours, not to exceed 8 caplets in 24 hours
  • 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)

corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

LEADER

NDC 70000-0127-2

Extra Strength

Back & Body

Aspirin (NSAID), 500 mg | Caffeine, 32.5 mg

Pain Reliever | Pain Reliever Aid

Relieves Backaches

and Muscle Aches & Pains

COMPARE TO

BAYER® BACK & BODY


active ingredients

100% Money Back Guarantee

100 CAPLETS

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

Bayer AG, owner of the registered trademark Bayer®

Back & Body.       

50844            REV0222B41312

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com   1-800-200-6313

Essential to Care™ since 1979

 All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

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

the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the

Leader LOGO are trademarks or registered trademarks of

Cardinal Health. All other marks are the property of their

respective owners.

Leader 44-413
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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
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
    • have bloody or black stools
    • feel faint
    • 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Aspirin 500 mg (NSAID)*

Caffeine 32.5 mg

*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

  • gout
  • diabetes
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)