Acetaminophen Tablets 500 Mg

Acetaminophen Tablets 500 Mg
SPL v6
SPL
SPL Set ID 9d620700-5d00-475f-e053-2995a90a9a3f
Route
ORAL
Published
Effective Date 2020-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (0.5 g)
Inactive Ingredients
Titanium Dioxide Stearic Acid Starch, Corn Hypromelloses Polyethylene Glycol, Unspecified Povidone Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-30

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 8 tablets 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

For the temporary relief of minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

For the reduction of fever.

Dosage and Administration

Directions

  • do not use more than directed

Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:Do not give to children under 12 years of age

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

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.

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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

Section 51727-6

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Section 51945-4

NDC# 68599-4681-3

McKesson

Acetaminophen Tablets 500mg

Non-Aspirin

Used to reduce fever / Temporarily relieves aches and pains

2 per Pack / 250 packs per Box

MFR# 82468

Section 53413-1

Questions or comments?1-800-777-4908

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


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • muscular aches
  • minor arthritis pain
  • common cold
  • toothache
  • menstrual cramps

For the reduction of fever.

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

Adults and children: (12 years and older)Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:Do not give to children under 12 years of age

Warnings and Precautions (34071-1)

Warnings

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

  • more than 8 tablets 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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)

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.

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

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

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Section 51945-4 (51945-4)

NDC# 68599-4681-3

McKesson

Acetaminophen Tablets 500mg

Non-Aspirin

Used to reduce fever / Temporarily relieves aches and pains

2 per Pack / 250 packs per Box

MFR# 82468

Section 53413-1 (53413-1)

Questions or comments?1-800-777-4908

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


Advanced Ingredient Data


Raw Label Data

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