Acetaminophen Extra Strength 500 Mg

Acetaminophen Extra Strength 500 Mg
SPL v6
SPL
SPL Set ID 873f01dd-0701-5fd3-e053-2a95a90a6463
Route
ORAL
Published
Effective Date 2017-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Starch, Pregelatinized Corn Povidone Silicon Dioxide Hypromelloses Cellulose, Microcrystalline Stearic Acid Polyethylene Glycol, Unspecified Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: BH Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-07-31

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
  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • 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.

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 have ever had an allergic reaction to this product or any of its ingredients

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

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.

Directions
  •  do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • 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 more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Other Information
  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

Questions Or Comments

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children.

Overdose warning: Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (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.

Do not exceed recommended dosage.

Package Label.principal Display Panel

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Tylenol*.

NDC 71309-001-05 500 Caplets


Structured Label Content

Uses
  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • 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.

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 have ever had an allergic reaction to this product or any of its ingredients

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

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.

Directions
  •  do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • 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 more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Active Ingredient

(in each tablet)

Acetaminophen 500mg

Other Information
  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Inactive Ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

Questions Or Comments (Questions or Comments)

1-844-384-3723 (Mon-Fri 9AM-5PM EST) or www.safrelpharma.com

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.)

Overdose warning: Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (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.

Do not exceed recommended dosage.

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

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Tylenol*.

NDC 71309-001-05 500 Caplets


Advanced Ingredient Data


Raw Label Data

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