Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e1ca0b60-0477-4b41-811f-82426d0849d6
Route
ORAL
Published
Effective Date 2010-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)

Identifiers & Packaging

Pill Appearance
Imprint: A500 Shape: round Shape: capsule Color: white Size: 13 mm Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-15
Description

                        Acetaminophen 500mg

Purpose

Pain Reliever/fever reducer

Medication Information

Purpose
Pain Reliever/fever reducer

Description

                        Acetaminophen 500mg

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever

Section 51945-4

non-aspirin 50 tablet

Warnings



Directions
  • do not take more than directed (see overdose warning)


adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years

 do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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

Liver Warning:
this product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information

  • do not use if imprinted safety seal under cap is broken or missing.
  • store between 20-25 °C (68-77°F)
  • see end panel for lot number and expiration date
Overdose Warning:

Taking more than the recommended dose(overdose) may cause liver damage.  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.

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
These could be sign of a serious condition

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children.

Enter section text here

Active Ingredients (in Each Tablet)

                       

Acetaminophen 500mg



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
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • temporarily reduces fever

Section 51945-4 (51945-4)

non-aspirin 50 tablet

Purpose
Pain Reliever/fever reducer

Warnings



Directions
  • do not take more than directed (see overdose warning)


adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 8 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
children under 12 years

 do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
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

Liver Warning:
this product contains acetaminophen.  Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information

  • do not use if imprinted safety seal under cap is broken or missing.
  • store between 20-25 °C (68-77°F)
  • see end panel for lot number and expiration date
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose(overdose) may cause liver damage.  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.

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
These could be sign 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.)

Enter section text here

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

                       

Acetaminophen 500mg



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: 2026-02-15T11:55:06.495994 · Updated: 2026-03-14T22:52:26.166879