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.

Active Ingredient

Active ingredient (in each tablet)

Acetaminophen 500 mg

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 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

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.

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Acetaminophen 500 mg

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

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 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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