Kroger Acetaminophen 500mg Gelcaps

Kroger Acetaminophen 500mg Gelcaps
SPL v2
SPL
SPL Set ID 30d3f2d0-da35-7f6f-e063-6294a90a9c22
Route
ORAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
D&c Red No. 33 Ferric Oxide Yellow Talc Fd&c Red No. 40 Starch, Corn Titanium Dioxide Ferrosoferric Oxide Hypromellose, Unspecified Stearic Acid Croscarmellose Sodium Ferric Oxide Red Fd&c Blue No. 1 Fd&c Yellow No. 6 Povidone Silica Gelatin, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-26
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:

- headache

- muscular aches

- backache

- minor pain of arthritis

- the common cold

- toothache

- premenstrual and menstrual cramps

  • temporarily reduces fever
Dosage and Administration

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

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 50570-1

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
Section 51727-6

Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Section 51945-4

Acetaminophen 500 mg Gelcaps 24ct carton

Acetaminophen 500 mg Gelcaps 24ct Label

Acetaminophen 500 mg Gelcaps 100ct carton

Acetaminophen 500 mg Gelcaps 100ct Label

Acetaminophen 500 mg Gelcaps 225ct carton

Acetaminophen 500 mg Gelcaps 225ct label

Section 53413-1

Questions or comments? Call 1-800-632-6900

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Section 60561-8

Other information

  • each gelcap contains: sodium 1 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
  • avoid high humidity

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:

- headache

- muscular aches

- backache

- minor pain of arthritis

- the common cold

- toothache

- premenstrual and menstrual cramps

  • temporarily reduces fever
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

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 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

Inactive ingredients colloidal anhydrous silica, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Section 51945-4 (51945-4)

Acetaminophen 500 mg Gelcaps 24ct carton

Acetaminophen 500 mg Gelcaps 24ct Label

Acetaminophen 500 mg Gelcaps 100ct carton

Acetaminophen 500 mg Gelcaps 100ct Label

Acetaminophen 500 mg Gelcaps 225ct carton

Acetaminophen 500 mg Gelcaps 225ct label

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-632-6900

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each gelcap)

Acetaminophen USP 500 mg

Section 60561-8 (60561-8)

Other information

  • each gelcap contains: sodium 1 mg
  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F)
  • avoid high humidity

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:10.557503 · Updated: 2026-03-14T23:08:48.977444