Acetaminophen 500 Mg Tablets

Acetaminophen 500 Mg Tablets
SPL v2
SPL
SPL Set ID ab79fd60-8315-4c63-8045-1b0511ac268f
Route
ORAL
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Magnesium Stearate Povidone

Identifiers & Packaging

Pill Appearance
Imprint: A500 Shape: round Color: white Size: 5 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-06

Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg

Uses

To reduce fever and for the temporary relief of minor aches and pains due to:

•headache

•muscular aches

•backache

•minor pain of arthritis

•the common cold

•toothache

•premenstrual and menstrual cramps.

•Temporarily reduces fever.

Section 50568-5

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

Section 51945-4

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 

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours 
  • taken with other drugs containing acetaminophen 
  • adult has 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.

Do Not Use
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.
Other Information
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients:

Gelatinized starch, magnesium stearate, povidone

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for

Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

*This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

Stop Use and Ask A Doctor If:
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

Keep Out of Reach of Children.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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 the User Has
  • has liver disease
  • is a child with pain of arthritis
Directions Do Not Take More Than Directed (see Overdose Warning)
 adults & 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


Structured Label Content

Uses

To reduce fever and for the temporary relief of minor aches and pains due to:

•headache

•muscular aches

•backache

•minor pain of arthritis

•the common cold

•toothache

•premenstrual and menstrual cramps.

•Temporarily reduces fever.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin

Section 51945-4 (51945-4)

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 

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours 
  • taken with other drugs containing acetaminophen 
  • adult has 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.

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if the user has ever had an allergic reaction to this product or any of its ingredients.
Other Information (Other information)
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients:

Gelatinized starch, magnesium stearate, povidone

Questions Or Comments? (Questions or Comments?)

Call toll-free 1-877-225-6999

Manufactured for

Akron Pharma, Inc.,

373 RT US46 W Building E,

Suite 117, Fairfeld, NJ - 07004

*This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. 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 the User Has (Ask a doctor before use if the user has)
  • has liver disease
  • is a child with pain of arthritis
Directions Do Not Take More Than Directed (see Overdose Warning) (Directions - do not take more than directed (see overdose warning))
 adults & 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


Advanced Ingredient Data


Raw Label Data

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