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
Purpose

Pain reliever / fever reducer

Description

Acetaminophen

Medication Information

Active Ingredient

Acetaminophen

Purpose

Pain reliever / fever reducer

Inactive Ingredients

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

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
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.

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

Active Ingredient (Active Ingredient (in each tablet))

Acetaminophen

Purpose

Pain reliever / fever reducer

Inactive Ingredients

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

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.

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
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.

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

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