MedPath

McKesson Acetaminophen 325

McKesson Acetaminophen 325 mg

Approved
Approval ID

bc2daba5-ce8b-bbda-e053-2a95a90a6f33

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

McKesson Medical-Surgical, Inc.

DUNS: 023904428

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68599-4679
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (8)

HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/3/2022

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

145R Acetaminophen

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/25/2021

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/25/2021

​Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/25/2021

Active ingredient (in each tablet)

Acetaminophen 325 mg

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/25/2021

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidne, pregelantinized starch, sodium starch glycolate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/25/2021

**Questions or comments?**Call 1-800-777-4908

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/25/2021

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 2/25/2021

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.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 2/25/2021

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

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 2/25/2021

Ask a doctor before use if you have

■ liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

LOINC: 50568-5Updated: 2/25/2021

Ask a doctor or pharmacist before use if

■ you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 2/25/2021

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/25/2021

Keep out of reach of children.

Overdose Warning:

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/25/2021

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/25/2021

Other information

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

■ tamper-evident sealed packets

■ do not use any opened or torn packets

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