SPL v1
SPL
SPL Set ID 35483db0-d6b8-4b37-8113-1dbe51e42ae5
Route
ORAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Pregelatinized Corn Hypromelloses Magnesium Stearate Polyethylene Glycol, Unspecified Cellulose, Microcrystalline Povidone Titanium Dioxide Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: S500 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if you haveliver disease

Section 53414-9

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

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, unless directed by a doctor; do not take 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
Questions? 

call toll-free 1-844-912-4012

Other Information
  • store between 20-25˚C (68-77˚F)
Overdose Warning:

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

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone, Stearic Acid, Talc, Titanium Dioxide

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.

Principal Display Panel 100 Count

Principal Display Panel 250 Count

Principal Display Panel 500 Count

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

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)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver disease

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

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, unless directed by a doctor; do not take 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
Questions? 

call toll-free 1-844-912-4012

Other Information (Other information)
  • store between 20-25˚C (68-77˚F)
Overdose Warning: (Overdose warning:)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 (Inactive ingredients)

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose , Pregelatinized Starch, Polyethylene Glycol, Povidone, Stearic Acid, Talc, Titanium Dioxide

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.

Principal Display Panel 100 Count (PRINCIPAL DISPLAY PANEL-100 Count)

Principal Display Panel 250 Count (PRINCIPAL DISPLAY PANEL-250 Count)

Principal Display Panel 500 Count (PRINCIPAL DISPLAY PANEL-500 Count)

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:16.917146 · Updated: 2026-03-14T23:08:56.104871