Extra Strength

Extra Strength
SPL v6
SPL
SPL Set ID 08f5af1d-365b-a97c-e063-6394a90a99ae
Route
ORAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Polyethylene Glycol, Unspecified Povidone K30 Sucralose Lecithin, Soybean Titanium Dioxide Fd&c Red No. 40 Fd&c Yellow No. 6 Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: L;1 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-09

Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 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

Section 55106-9

Acetaminophen USP, 500 mg

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 are allergic to acetaminophen or any of the inactive ingredients in 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

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

Other Information



■ store at 20-25°C (68-77°F). See USP Controlled Room Temperature.

■ see end panel for lot number and expiration date

Inactive Ingredients



FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

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 childreneven if you do not notice any signs or symptoms.



Ask A Doctor Before Use If You Have

liver disease

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

Section 55106-9 (55106-9)

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer

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 are allergic to acetaminophen or any of the inactive ingredients in this product

Allergy Alert: (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

Liver Warning: (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

Other Information (Other information)



■ store at 20-25°C (68-77°F). See USP Controlled Room Temperature.

■ see end panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)



FD&C red no. 40, FD&C yellow no. 6, lecithin, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel (Principal display panel)

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 childreneven if you do not notice any signs or symptoms.



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

liver disease

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


Raw Label Data

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