Topco Associates Llc. Extra Strength Pain Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Starch, Corn Fd&c Red No. 40 Aluminum Lake Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Stearic Acid Sucralose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L31G Shape: round Color: red Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2020-11-11 Until 2023-07-31

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 tablets every 6 hours while symptoms last • do not take more than 6 tablets 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 have ever had an allergic reaction to this product or any of its ingredients

Inactive Ingredients

corn starch*, FD&C red #40 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *may contain these ingredients

Questions Or Comments?

1-888-423-0139

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 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.

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have

liver disease

Package/label Principal Display Panel

TopCare_® health

COMPARE TO EXTRA STRENGTH TYLENOL^® ACTIVE INGREDIENT

EXTRA STRENGTH

Pain Relief

ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

• Easy to Swallow • Sweet Coated

100 TABLETS

For Adults

actual size

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 tablets every 6 hours while symptoms last • do not take more than 6 tablets 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 have ever had an allergic reaction to this product or any of its ingredients

Inactive Ingredients (Inactive ingredients)

corn starch*, FD&C red #40 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *may contain these ingredients

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 500 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Package/label Principal Display Panel (Package/Label Principal Display Panel)

TopCare_® health

COMPARE TO EXTRA STRENGTH TYLENOL^® ACTIVE INGREDIENT

EXTRA STRENGTH

Pain Relief

ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

• Easy to Swallow • Sweet Coated

100 TABLETS

For Adults

actual size

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

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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", "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 tablets every 6 hours while symptoms last • do not take more than 6 tablets 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 have ever had an allergic reaction to this product or any of its ingredients", "Inactive ingredients": "corn starch*, FD&C red #40 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide *may contain these ingredients", "Questions or comments?": "1-888-423-0139", "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 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.", "Active ingredient (in each tablet)": "Acetaminophen 500 mg", "Ask a doctor before use if you have": "liver disease", "Package/Label Principal Display Panel": "TopCare ® health COMPARE TO EXTRA STRENGTH TYLENOL ® ACTIVE INGREDIENT EXTRA STRENGTH Pain Relief ACETAMINOPHEN 500 mg PAIN RELIEVER • FEVER REDUCER • Easy to Swallow • Sweet Coated 100 TABLETS For Adults actual size", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Topco Associates Llc. Extra Strength Pain Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information