Pain Reliever

Pain Reliever
SPL v7
SPL
SPL Set ID 175495fd-c561-f813-e063-6294a90aac80
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Ammonia Hydroxypropyl Cellulose, Unspecified Croscarmellose Sodium D&c Red No. 33 Ferrosoferric Oxide Gelatin Hypromellose, Unspecified Ferric Oxide Red Butyl Alcohol Polyethylene Glycol, Unspecified Starch, Corn Propylene Glycol Povidone K30 Fd&c Red No. 40 Titanium Dioxide Isopropyl Alcohol Fd&c Yellow No. 6 Silicon Dioxide Ferric Oxide Yellow Shellac Stearic Acid Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: G;1 Shape: capsule Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-16
Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold n toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 51945-4

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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
Allergy Alert:

acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seekmedical help right away

Liver Warning:

This product contains acetaminophen. Severe liverdamage may occur if you take

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information
  • store at 20°-25°C (68°-77°F)
  • avoid high humidity
  • see bottom of the label for expiration date and lot number
Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40,

FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30,

pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide

Questions Or Comments?

1-888-287-1915

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

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.

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredient (in Each Gelcap)

Acetaminophen USP, 500 mg

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold n toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 51945-4 (51945-4)

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over

  • take 2 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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
Allergy Alert: (Allergy alert:)

acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seekmedical help right away

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liverdamage may occur if you take

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
  • avoid high humidity
  • see bottom of the label for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40,

FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30,

pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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)

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Active Ingredient (in Each Gelcap) (Active ingredient (in each gelcap))

Acetaminophen USP, 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:49.032829 · Updated: 2026-03-14T23:11:40.308391