Extra Strength Pain Relief

SPL v2

SPL

SPL Set ID 8e96f75c-de8e-472a-aadb-3767dc64dfc6

Route

ORAL

Published

Effective Date 2019-12-30

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

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-07-22

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

Directions

do not take more than directed (see Overdose warning)

adults and children 12 years of age 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 of age	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: 248-449-9300

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.

Principal Display Panel 40ct

Extra Strength Pain Relief

Acetaminophen, 500mg 40 Liquid Gels

NDC 63868-863-40

*Compare to the active ingredient in TYLENOL® Extra Strength

Principal Display Panel 80ct

Extra Strength Pain Relief

Acetaminophen, 500mg 80 Liquid Gels

NDC 63868-863-80

*Compare to the active ingredient in TYLENOL® Extra Strength

Active Ingredient (in Each Softgel)

Acetaminophen 500 mg

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

Directions

do not take more than directed (see Overdose warning)

adults and children 12 years of age 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 of age	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: 248-449-9300

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.

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

Extra Strength Pain Relief

Acetaminophen, 500mg 40 Liquid Gels

NDC 63868-863-40

*Compare to the active ingredient in TYLENOL® Extra Strength

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

Extra Strength Pain Relief

Acetaminophen, 500mg 80 Liquid Gels

NDC 63868-863-80

*Compare to the active ingredient in TYLENOL® Extra Strength

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

Acetaminophen 500 mg

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", "Directions": "do not take more than directed ( see Overdose warning) adults and children 12 years of age 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 of age 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: 248-449-9300", "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.", "PRINCIPAL DISPLAY PANEL - 40ct": "Extra Strength Pain Relief Acetaminophen, 500mg 40 Liquid Gels NDC 63868-863-40 *Compare to the active ingredient in TYLENOL® Extra Strength", "PRINCIPAL DISPLAY PANEL - 80ct": "Extra Strength Pain Relief Acetaminophen, 500mg 80 Liquid Gels NDC 63868-863-80 *Compare to the active ingredient in TYLENOL® Extra Strength", "Active ingredient (in each softgel)": "Acetaminophen 500 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:59.550377 · Updated: 2026-03-14T22:55:48.069158