Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 943c8f49-e65e-40bc-b364-3274df4d21a2
Route
ORAL
Published
Effective Date 2024-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Povidone, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 44;148 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-20
Description

Acetaminophen

Purpose

Pain reliever / fever reducer

Medication Information

Purpose

Pain reliever / fever reducer

Description

Acetaminophen

Uses:

For the temporary relief of minor aches and pains associated with:

  • headache
  • toothache
  • muscular aches
  • common cold
  • minor arthritis pain
  • menstrual cramps
  • For the reduction of fever
Section 42229-5

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
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions:

Do not use more than directed

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
Other Information:
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Corn starch, unspecified povidone, sodium starch glycolate, stearic acid

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.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 Tablet)

Acetaminophen

Ask A Doctor Before Use If You Have:
  • Liver disease
Adults and Children 12 Years and Over
  • take 2 tablets every 6 hours while symptoms persist or as directed by a doctor.
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
Ask A Doctor Or Pharmacist Before Us If You Are:
  • taking the blood thinning drug warfarin
Principal Display Panel – 250 Tablet Box Label

2522

Maximum Strength Pain Reliever

ASPIRIN FREE

COMPARE TO

TYLENOL

For Temporary

Relief of Minor

Aches and Pains

250 tablets

2 Per Packet

The Provision

First Aid

Line™

BY WILDMAN

Structured Label Content

Uses:

For the temporary relief of minor aches and pains associated with:

  • headache
  • toothache
  • muscular aches
  • common cold
  • minor arthritis pain
  • menstrual cramps
  • For the reduction of fever
Section 42229-5 (42229-5)

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
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever / fever reducer

Directions:

Do not use more than directed

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
Other Information: (Other information:)
  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Inactive Ingredients

Corn starch, unspecified povidone, sodium starch glycolate, stearic acid

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.

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 Tablet) (Active Ingredient (in each tablet))

Acetaminophen

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • Liver disease
Adults and Children 12 Years and Over (Adults and children 12 years and over)
  • take 2 tablets every 6 hours while symptoms persist or as directed by a doctor.
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
Ask A Doctor Or Pharmacist Before Us If You Are: (Ask a doctor or pharmacist before us if you are:)
  • taking the blood thinning drug warfarin
Principal Display Panel – 250 Tablet Box Label

2522

Maximum Strength Pain Reliever

ASPIRIN FREE

COMPARE TO

TYLENOL

For Temporary

Relief of Minor

Aches and Pains

250 tablets

2 Per Packet

The Provision

First Aid

Line™

BY WILDMAN

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:07.050430 · Updated: 2026-03-14T23:02:58.626725