physicianscare non aspirin extra strength (acetaminophen)

physicianscare non aspirin extra strength (acetaminophen)
SPL v12
SPL
SPL Set ID c7006775-bd5b-412f-963d-ce5a158216c5
Route
oral
Published
Effective Date 2023-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
hypromelloses povidone sodium starch glycolate type a potato starch, corn stearic acid titanium dioxide polyethylene glycol, unspecified

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2012-01-20

Description

Drug Facts


Medication Information

Warnings and Precautions

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

temporarily relieves minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ toothache

■ menstrual cramps

■ common cold

temporarily reduces fever

Dosage and Administration

Directions

do not use more than directed

Adults and children: (12 years and older)

  • take 2 tablets every 6 hours as needed.
  • do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Description

Drug Facts

Section 34076-0

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ do not use any opened or torn packets

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

Stop use and ask a doctor if

■ symptoms do not improve

■ redness or swelling is present

■ pain or fever persists or gets worse

■ new symptoms occur

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.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

Section 51727-6

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.

Section 53413-1

Questions? 1-800-835-2263

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Physicianscare Xs Non Aspirin Label

Physicians Care®

Extra Strength Non Aspirin

Pain Reliever and Fever Reducer

Pull To Open

Coated Tablets

Individually packaged for workplace use

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aceatminiphen 500 mg

100 Tablets (50 Packets, 2 tablets each)

90016


Structured Label Content

Warnings and Precautions (34071-1)

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

temporarily relieves minor aches and pains associated with

■ headache

■ muscular aches

■ minor arthritis pain

■ toothache

■ menstrual cramps

■ common cold

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

do not use more than directed

Adults and children: (12 years and older)

  • take 2 tablets every 6 hours as needed.
  • do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Section 34076-0 (34076-0)

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ do not use any opened or torn packets

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)

Stop use and ask a doctor if

■ symptoms do not improve

■ redness or swelling is present

■ pain or fever persists or gets worse

■ new symptoms occur

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.

■ for more than 10 days for pain unless directed by a doctor

■ for more than 3 days for fever unless directed by a doctor

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide.

Section 53413-1 (53413-1)

Questions? 1-800-835-2263

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

Physicianscare Xs Non Aspirin Label (PhysiciansCare XS Non Aspirin Label)

Physicians Care®

Extra Strength Non Aspirin

Pain Reliever and Fever Reducer

Pull To Open

Coated Tablets

Individually packaged for workplace use

Tamper-Evident Packets of 2 Tablets

Do not use if packet is open or torn.

Aceatminiphen 500 mg

100 Tablets (50 Packets, 2 tablets each)

90016


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)