pain reliever 500mg (minis-red opaque)

pain reliever 500mg (minis-red opaque)
SPL v2
SPL
SPL Set ID 3a801457-c5d0-b134-e063-6294a90ac5cb
Route
oral
Published
Effective Date 2025-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
polyethylene glycol, unspecified povidone gelatin titanium dioxide water sorbitol fd&c red no. 40 polyethylene glycol 400 glycerin

Identifiers & Packaging

Pill Appearance
Imprint: 36 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-08-04

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

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.

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

Other Information
  • store between 15°-30°C (59°-86°F)
Inactive Ingredients

FD&C red no.40, gelatin, glycerin, polyethylene glycol 40 ,polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Description

Drug Facts

Section 34088-5

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 for critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 51945-4

Section 53413-1

Questions or comments?1-888-333-9792

Section 53414-9



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

Direction

Do not take more than directed (see Overdose warning)

adults and children 12 yeards and over
  • take 2 softgels every 6 hours while symptoms last
  • do not take more than 6 softgels 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

Active Ingredient (in Each Softgelatin Capsule)

Acetaminophen 500mg


Structured Label Content

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.

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

Other Information
  • store between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

FD&C red no.40, gelatin, glycerin, polyethylene glycol 40 ,polyethylene glycol 400, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Section 34088-5 (34088-5)

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 for critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-888-333-9792

Section 53414-9 (53414-9)



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

Direction

Do not take more than directed (see Overdose warning)

adults and children 12 yeards and over
  • take 2 softgels every 6 hours while symptoms last
  • do not take more than 6 softgels 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

Active Ingredient (in Each Softgelatin Capsule) (Active ingredient (in each softgelatin capsule))

Acetaminophen 500mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)