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.

Active Ingredient



Active ingredient (in each tablet)

Acetaminophen 500 mg

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 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

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.

Active Ingredient (55106-9)



Active ingredient (in each tablet)

Acetaminophen 500 mg

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

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 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

All Sections (JSON)