Extra Strength

Extra Strength
SPL v5
SPL
SPL Set ID 0c8e7095-0806-4501-e063-6394a90a89aa
Route
ORAL
Published
Effective Date 2024-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone Stearic Acid Polyethylene Glycol, Unspecified Hypromellose, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: G;551 Shape: oval Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-13

Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500 mg

Pdp

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 ■ take 2 caplets every 6 hours while symptoms last

■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

12 years and over

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

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

■ see bottom of the label for lot number and expiration date

Inactive Ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

We would love to hear about your Member’s Mark experience! Call us toll-free at 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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

Keep out of reach of children

Active Ingredient (in Each Caplet)

Acetaminophen USP, 500 mg

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

Pdp (PDP)

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 ■ take 2 caplets every 6 hours while symptoms last

■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

■ do not use for more than 10 days unless directed by a doctor

12 years and over

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

Overdose Warning (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 (Other information)

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

■ see bottom of the label for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

We would love to hear about your Member’s Mark experience! Call us toll-free at 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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)

Keep out of reach of children

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen USP, 500 mg

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

All Sections (JSON)