Acetaminophen 500 Mg

Acetaminophen 500 Mg
SPL v20
SPL
SPL Set ID 56822785-d5fb-4869-971e-5de637c2eda8
Route
ORAL
Published
Effective Date 2023-03-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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.

Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backahe
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration

Directions

  • do not use more than directed (see overdose warning)



Adults and 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

Description

Drug Facts

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 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.

Section 50566-9

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Section 50568-5

Ask a doctor or 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 ingredients in this product
Section 51727-6

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*,purified water*, sodium starch glycolate, stearic acid*, titanium dioxide*

*may contain

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medique Extra Strength Apap

Medique®

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

Compare active ingredient to Tylenol®

Registered McNeil Consumer Products

Tamper Evident Unit Dose Packets

Medi First Extra Strength Non Aspirin

Medi-First®

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

Aches, Fever ● Acetaminophen 500mg

Pull to Open

Compare active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Extra Strength Non Aspirin

Medi First®

Plus

Extra Strength

Non-Aspirin

Acetaminophen 500 mg

Pull To Open

This Package is For Households Without Young Children.

Pain Reliever/Fever Reducer

Compare Active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2's)


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backahe
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not use more than directed (see overdose warning)



Adults and 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

Warnings and Precautions (34071-1)

Warnings

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

  • more than 4,000 mg in 24 hours, which is the maximum daily amount
  • 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.

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 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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or 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 ingredients in this product
Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, hypromellose*, polyethylene glycol*, povidone (K-30)*, pregelatinized starch*,purified water*, sodium starch glycolate, stearic acid*, titanium dioxide*

*may contain

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 500 mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets
Medique Extra Strength Apap (Medique Extra Strength APAP)

Medique®

Extra Strength

APAP

Non-Aspirin Tablets

This Package is For Households Without Young Children

Pain Reliever/Fever Reducer ● Acetaminophen 500mg

Compare active ingredient to Tylenol®

Registered McNeil Consumer Products

Tamper Evident Unit Dose Packets

Medi First Extra Strength Non Aspirin (Medi-First Extra Strength Non Aspirin)

Medi-First®

Extra Strength

Non-Aspirin

Pain Reliever/Fever Reducer

Aches, Fever ● Acetaminophen 500mg

Pull to Open

Compare active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

This Package is for Households without Young Children.

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2)

Medi First Plus Extra Strength Non Aspirin (Medi First Plus Extra Strength Non-Aspirin)

Medi First®

Plus

Extra Strength

Non-Aspirin

Acetaminophen 500 mg

Pull To Open

This Package is For Households Without Young Children.

Pain Reliever/Fever Reducer

Compare Active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer

Tamper Evident Unit Dose Packets

100 Tablets

(50 x 2's)


Advanced Ingredient Data


Raw Label Data

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