Acetaminophen Extra Strength 500 Mg

Acetaminophen Extra Strength 500 Mg
SPL v2
SPL
SPL Set ID bba2ddc5-19e0-4f11-8ff7-7dd7c2d53b50
Route
ORAL
Published
Effective Date 2018-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Corn Povidone K30 Sodium Metabisulfite Silicon Dioxide Hypromellose 2910 (15 Mpa.s) Cellulose, Microcrystalline Croscarmellose Sodium Stearic Acid Sodium Starch Glycolate Type A Potato Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 1000 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P500 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-05-14

Description

(in each tablet) Acetaminophen 500mg

Purpose

pain reliever/fever reducer


Medication Information

Purpose

pain reliever/fever reducer

Description

(in each tablet) Acetaminophen 500mg

Uses
  • temporarily reduces fever
Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

ask a doctor before use if you have liver disease

ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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 appear
  • these could be signs of a serious condition

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

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 of this product in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

    children under 12 years:

  • Ask a doctor
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Other Information
  • Store at a controlled temperature between  62° and 77 °F)
Inactive Ingredients

P.G Starch, P.V.P.K.30, sodium metabisulfite, colloidal silicon dioxide, Hypromellose-15, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Sodium Starch Glycolate, Hypromellose-6, Polyethylene Glycol, Titanium Dioxide.

Questions Or Comments

Questions? 1-855-314-1850

Keep Out of Reach of Children.

Overdose warning: Taking more than 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.

Package Label.principal Display Panel


Structured Label Content

Uses
  • 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 4000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

do not use

  • with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.

ask a doctor before use if you have liver disease

ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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 appear
  • these could be signs of a serious condition

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

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 of this product in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

    children under 12 years:

  • Ask a doctor
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Other Information
  • Store at a controlled temperature between  62° and 77 °F)
Inactive Ingredients

P.G Starch, P.V.P.K.30, sodium metabisulfite, colloidal silicon dioxide, Hypromellose-15, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Sodium Starch Glycolate, Hypromellose-6, Polyethylene Glycol, Titanium Dioxide.

Questions Or Comments (Questions or Comments)

Questions? 1-855-314-1850

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

Overdose warning: Taking more than 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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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