Leader 44-519
dd8b13a5-07df-4cec-92c3-1a662b1e1a56
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Acetaminophen 500 mg
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Do Not Use
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0312-1
Extra Strength
Acetaminophen
Gelcaps, 500 mg | Pain Reliever / Fever Reducer
Aspirin-Free
50 GELCAPS
Actual Size
COMPARE TO
TYLENOL® EXTRA
STRENGTH RAPID
RELEASE GELS
active ingredient*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark Tylenol®
Extra Strength Rapid Release Gels.
50844 REV0525C51915
©2026 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.
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.
Stop Use and Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient (in Each Gelcap)
Acetaminophen 500 mg
Ask A Doctor Before Use If You Have
liver disease.
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Structured Label Content
Uses
- temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain from arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Purpose
Pain reliever/fever reducer
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 gelcaps every 6 hours while symptoms last
- do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Do Not Use (Do not use)
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Other Information (Other information)
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)
croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide
Questions Or Comments? (Questions or comments?)
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0312-1
Extra Strength
Acetaminophen
Gelcaps, 500 mg | Pain Reliever / Fever Reducer
Aspirin-Free
50 GELCAPS
Actual Size
COMPARE TO
TYLENOL® EXTRA
STRENGTH RAPID
RELEASE GELS
active ingredient*
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark Tylenol®
Extra Strength Rapid Release Gels.
50844 REV0525C51915
©2026 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.
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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms appear
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))
Acetaminophen 500 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
liver disease.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
taking the blood thinning drug warfarin.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:18.627710 · Updated: 2026-03-14T23:12:31.383435