Acetaminophen Capsules Usp 500mg (minis - Red Opaque)

Acetaminophen Capsules Usp 500mg (minis - Red Opaque)
SPL v5
SPL
SPL Set ID 352bb451-ffdc-411a-e063-6294a90a8cf5
Route
ORAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Glycerin Sorbitol Polyethylene Glycol 400 Fd&c Red No. 40 Titanium Dioxide Water Gelatin Povidone K30 Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-17

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

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.

Directions

do not take more than directed (see overdose warning).

adults and children 12 years and over

• take 2 capsules every 6 hours while symptoms last

•do not take more than 6 capsules 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.

Package Label

Other Information

  • store between 20-25°C (68-77°F)
Inactive Ingredients

FD&C red 40, gelatin,glycerin, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, povidone K30,purified water, sorbitol sorbitan solution, 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warnings:

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

Active Ingredient (in Each Softgel)

Acetaminophen 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:

• the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever

Purpose

Pain reliever/fever reducer

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.

Directions

do not take more than directed (see overdose warning).

adults and children 12 years and over

• take 2 capsules every 6 hours while symptoms last

•do not take more than 6 capsules 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.

Package Label (package label)

Other Information (Other information)

  • store between 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

FD&C red 40, gelatin,glycerin, polyethylene glycol 400, polyoxyl 40 hydrogenated castor oil, povidone K30,purified water, sorbitol sorbitan solution, 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.

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

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warnings:

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

Active Ingredient (in Each Softgel) (Active ingredient (in each Softgel))

Acetaminophen 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)