Careone 44-519

Careone 44-519
SPL v15
SPL
SPL Set ID bc19bd47-69ea-4bcc-8d28-c043c9d32513
Route
ORAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin, Unspecified Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L;5 Shape: oval Color: red Color: blue Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-05-10
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:
    • toothache
    • muscular aches
    • the common cold
    • headache
    • backache
    • minor pain from arthritis
    • 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:

  • blisters
  • rash
  • skin reddening

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • use by expiration date on package
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

CAREONE®

NDC 41520-919-20

Compare to the

active ingredient in

Extra Strength Tylenol®

Rapid Release Gels*

Extra Strength

ACETAMINOPHEN

500 mg

Pain Reliever

Fever Reducer



Contains no aspirin

OUR PHARMACIST

Rx

RECOMMEND 

225

GELCAPS

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 Kenvue Inc., owner of the

registered trademark Extra Strength Tylenol® Rapid Release Gels.

50844 REV0525B51920

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

Care one 44-519
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
  • any new symptoms appear
  • redness or swelling is present
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:
    • toothache
    • muscular aches
    • the common cold
    • headache
    • backache
    • minor pain from arthritis
    • 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:

  • blisters
  • rash
  • skin reddening

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity
  • use by expiration date on package
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

CAREONE®

NDC 41520-919-20

Compare to the

active ingredient in

Extra Strength Tylenol®

Rapid Release Gels*

Extra Strength

ACETAMINOPHEN

500 mg

Pain Reliever

Fever Reducer



Contains no aspirin

OUR PHARMACIST

Rx

RECOMMEND 

225

GELCAPS

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 Kenvue Inc., owner of the

registered trademark Extra Strength Tylenol® Rapid Release Gels.

50844 REV0525B51920

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

Care one 44-519
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
  • any new symptoms appear
  • redness or swelling is present
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: 2026-02-15T12:08:29.785352 · Updated: 2026-03-14T23:12:44.067976