35483db0-d6b8-4b37-8113-1dbe51e42ae5

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
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

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
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
Other Information
  • store between 20-25˚C (68-77˚F)
Inactive Ingredients

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

Description

Drug Facts

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.

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

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.

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
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
Other Information (Other information)
  • store between 20-25˚C (68-77˚F)
Inactive Ingredients (Inactive ingredients)

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

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.

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

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.

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