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

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

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.

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.

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

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

Active Ingredient (in Each Softgelatin Capsule)

Acetaminophen 500mg

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

Section 34088-5 (34088-5)

Overdose Warning

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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)

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.

Purpose

Pain reliever/fever reducer

Warnings

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.

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

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

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

Acetaminophen 500mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "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.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "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.", "53413-1": "Questions or comments? 1-888-333-9792", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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.", "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", "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", "Active ingredient (in each softgelatin capsule)": "Acetaminophen 500mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:59.678420 · Updated: 2026-03-14T23:12:06.957806