Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 59eb14a5-40b0-4331-beb5-7166e6cdf411
Route
ORAL
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Hypromelloses Lactose Monohydrate Magnesium Stearate Mineral Oil Polyethylene Glycol, Unspecified Povidone Water Sodium Starch Glycolate Type A Corn Stearic Acid Talc Titanium Dioxide Polyvinyl Alcohol, Unspecified Maltodextrin Medium-chain Triglycerides Polydextrose

Identifiers & Packaging

Pill Appearance
Imprint: TCL341;AV;0821;P500 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2016-03-31 Until 2026-12-31
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 of 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 ever 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 a medical help right away.

Directions
  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Product Label
READYinCASE Pain Reliever
Other Information
  • store between 20-25°C (68-77°F)
Inactive Ingredients

corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*,maltodextrin*, medium-chain triglycerides*, mineral oil*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Tylenol® Extra Strength†

Extra Strength

Pain Reliever

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 Caplet)

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 of 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 ever 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 a medical help right away.

Directions
  • do not take more than directed (see Overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use
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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Product Label
READYinCASE Pain Reliever
Other Information (Other information)
  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*,maltodextrin*, medium-chain triglycerides*, mineral oil*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Tylenol® Extra Strength†

Extra Strength

Pain Reliever

Acetaminophen, 500 mg

Pain Reliever/Fever Reducer

Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

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
  • new symptoms occur
  • 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 Caplet) (Active ingredient (in each caplet))

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: 2026-02-15T12:06:48.003652 · Updated: 2026-03-14T23:09:46.965889