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.

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

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 500 mg

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

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.

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.

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

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 500 mg

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)