Extra Strength Pain Relief Acetaminophen 500 Mg

Extra Strength Pain Relief Acetaminophen 500 Mg
SPL v2
SPL
SPL Set ID 95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e
Route
ORAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Water Sodium Starch Glycolate Type A Corn Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-17

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5

Ask a doctor/pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
Section 50570-1

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 ingredient in this product.
Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8

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.
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
Directions
  • do not take more than directed (see overdose warning)

Adults and  children 12 years and over:

  • 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

Children under 12 Years

  • ask a doctor
Other Information
  • store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients

Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide

Questions Or Comments?

Call 1 (718) 337-8733 or visit: [email protected] 

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Overdose warning:  In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

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
  • redness or swelling is present
  • new symptoms occur

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor/pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
Section 50570-1 (50570-1)

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 ingredient in this product.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 60561-8 (60561-8)

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.
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
Directions
  • do not take more than directed (see overdose warning)

Adults and  children 12 years and over:

  • 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

Children under 12 Years

  • ask a doctor
Other Information (Other information)
  • store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide

Questions Or Comments? (Questions or comments?)

Call 1 (718) 337-8733 or visit: [email protected] 

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

Acetaminophen 500 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)