Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 67870e7a-88fd-43cf-97e8-cbf546ad4f3f
Route
ORAL
Published
Effective Date 2019-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromellose 2208 (15000 Mpa.s) Polyethylene Glycol, Unspecified Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: 500 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-12-30
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:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces 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 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have liver disease

Section 53414-9

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

Directions

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, unless directed by a doctor
  • do not use 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • Store the product at controlled room temperature 15°-30°C (59°-86°F).
  • Protect from light, moisture and freezing.
Inactive Ingredients

hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions Or Comments?

Call toll free: 1-800-456-7077

Stop Use and Ask A Doctor If
  • pain gets worse or last 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.

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Principal Display Panel – Pouch Label

DO NOT USE IF POUCH IS TORN OR DAMAGED

Safetec

of America, Inc.

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Structured Label Content

Uses
  • Temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces 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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Directions

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, unless directed by a doctor
  • do not use 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • Store the product at controlled room temperature 15°-30°C (59°-86°F).
  • Protect from light, moisture and freezing.
Inactive Ingredients (Inactive ingredients)

hypromellose, polyethylene glycol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-456-7077

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or last 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Principal Display Panel – Pouch Label

DO NOT USE IF POUCH IS TORN OR DAMAGED

Safetec

of America, Inc.

Manufactured for Safetec of America, Inc.

Buffalo NY 14215

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:00.481543 · Updated: 2026-03-14T22:55:50.118517