Pain Relief Extra Strength

SPL v2

SPL

SPL Set ID b98ba5fd-469b-4e4e-9a63-7765483b1d3e

Route

ORAL

Published

Effective Date 2019-11-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: PC24 Shape: capsule Color: red Size: 24 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-12-14

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 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.

Directions

do not take more than directed (see Overdose warning)

Adults and children 12 years 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 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

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.

Other Information

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call toll free 1-855-215-8180

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.

Active Ingredient (in Each Softgel)

Acetaminophen 500 mg

Principal Display Panel 40ct Bottle Label

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 40 Liquid Gels

NDC 69842-073-25

Compare to the active ingredient in TYLENOL^® Extra Strength

Principal Display Panel 80ct Bottle Label

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 80 Liquid Gels

NDC 69842-073-26

Compare to the active ingredient in TYLENOL^® Extra Strength

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 53414-9 (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.

Directions

do not take more than directed (see Overdose warning)

Adults and children 12 years 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 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

Overdose Warning (Overdose warning)

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments? (Questions or Comments?)

Call toll free 1-855-215-8180

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.

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

Acetaminophen 500 mg

Principal Display Panel 40ct Bottle Label (PRINCIPAL DISPLAY PANEL - 40ct Bottle Label)

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 40 Liquid Gels

NDC 69842-073-25

Compare to the active ingredient in TYLENOL^® Extra Strength

Principal Display Panel 80ct Bottle Label (PRINCIPAL DISPLAY PANEL - 80ct Bottle Label)

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 80 Liquid Gels

NDC 69842-073-26

Compare to the active ingredient in TYLENOL^® Extra Strength

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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.", "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.", "Directions": "do not take more than directed (see Overdose warning ) Adults and children 12 years 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 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", "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.", "Other information": "store at room temperature 15°-30°C (59°-86°F)", "Inactive ingredients": "FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink", "Questions or Comments?": "Call toll free 1-855-215-8180", "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.", "Active ingredient (in each softgel)": "Acetaminophen 500 mg", "PRINCIPAL DISPLAY PANEL - 40ct Bottle Label": "EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN 500 mg 40 Liquid Gels NDC 69842-073-25 Compare to the active ingredient in TYLENOL ® Extra Strength", "PRINCIPAL DISPLAY PANEL - 80ct Bottle Label": "EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN 500 mg 80 Liquid Gels NDC 69842-073-26 Compare to the active ingredient in TYLENOL ® Extra Strength"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:55.780990 · Updated: 2026-03-14T22:55:43.865902