Acetaminophen 500mg

Acetaminophen 500mg
SPL v1
SPL
SPL Set ID 09935a74-34b0-0e7c-e063-6294a90a7c83
Route
ORAL
Published
Effective Date 2023-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Stearic Acid Starch, Corn Sodium Starch Glycolate Type A Potato Povidone K30 Polyethylene Glycol, Unspecified Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: G551 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-08

Description

Acetaminophen USP, 500mg

Purpose

Pain Reliever / Fever Reducer


Medication Information

Purpose

Pain Reliever / Fever Reducer

Description

Acetaminophen USP, 500mg

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 relieves fever

Warnings

Liver warning

This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 4000mg 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 ad seek medical medical help right away

Directions

Do not take more than directed. See overdose warning

Adults and children 12 years and older

  • 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 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.

Package Label

Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

Made in the USA

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 children even if you do not notice symptoms.

Other Information
  • Store at 20ºC - 25ºC (68ºF - 77ºF). See USP controlled room temperature
  • Avoid high humidity
  • See end panel for expiration date and lot number
  • Tamper Evident. Do not use if imprinted safety seal under cap is broken or missing
  • Important. Read the directions and warnings before use
Inactive Ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycolate, Stearic Acid

Questions Or Comments?

Call 1-888-296-9067

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 a sign 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, 500mg

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 relieves fever

Purpose

Pain Reliever / Fever Reducer

Warnings

Liver warning

This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 4000mg 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 ad seek medical medical help right away

Directions

Do not take more than directed. See overdose warning

Adults and children 12 years and older

  • 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 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.

Package Label

Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

Made in the USA

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 children even if you do not notice symptoms.

Other Information
  • Store at 20ºC - 25ºC (68ºF - 77ºF). See USP controlled room temperature
  • Avoid high humidity
  • See end panel for expiration date and lot number
  • Tamper Evident. Do not use if imprinted safety seal under cap is broken or missing
  • Important. Read the directions and warnings before use
Inactive Ingredients

hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycolate, Stearic Acid

Questions Or Comments? (Questions or Comments?)

Call 1-888-296-9067

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 a sign 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, 500mg

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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