mckesson acetaminophen 325 mg

mckesson acetaminophen 325 mg
SPL v6
SPL
SPL Set ID bc2daba5-ce8b-bbda-e053-2a95a90a6f33
Route
oral
Published
Effective Date 2022-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg)
Inactive Ingredients
hypromellose, unspecified polyethylene glycol, unspecified titanium dioxide povidone, unspecified stearic acid starch, corn sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance
Imprint: AZ;234 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-04-01

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 325 mg

Indications and Usage

Uses

temporarily relieves of minor aches and pains due to:

■ headache

■ muscular aches

■ minor arthritis pain

■ backache

■ 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 4 to 6 hours while symptoms last.

■ do not take more than 10 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

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

Section 50566-9

Stop using and ask a doctor if

■ pain gets worse and 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, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4

NDC 68599-4679-9

This Package is for Households without Young Children.

McKesson

Acetaminophen

325 mg

Pain Reliever / Fever Reducer

2

Per Pack

250

Packs Per Box

MFR # 82467

Section 53413-1

Questions or comments? Call 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 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 325 mg

Indications and Usage (34067-9)

Uses

temporarily relieves of minor aches and pains due to:

■ headache

■ muscular aches

■ minor arthritis pain

■ backache

■ 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 4 to 6 hours while symptoms last.

■ do not take more than 10 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)

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

Section 50566-9 (50566-9)

Stop using and ask a doctor if

■ pain gets worse and 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, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Section 51945-4 (51945-4)

NDC 68599-4679-9

This Package is for Households without Young Children.

McKesson

Acetaminophen

325 mg

Pain Reliever / Fever Reducer

2

Per Pack

250

Packs Per Box

MFR # 82467

Section 53413-1 (53413-1)

Questions or comments? Call 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

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