Acetaminophen

Manufacturer: A-S Medication Solutions
Effective date: 2020-11-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:33:34

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • premenstrual and menstrual cramps • temporarily reduces fever

Dosage and administration

• do not take 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 • do not use for more than 10 days unless directed by a doctor children 6-11 years • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days un...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-616-2471

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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.

Do not use

OTC - DO NOT USE SECTION

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 the user has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

has liver disease
is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take 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
do not use for more than 10 days unless directed by a doctor

children

6-11 years

take 1 tablet every 4 to 6 hours while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a
doctor

children under

6 years

ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium*, povidone, pregelatinized starch, stearic acid

*may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4238

NDC: 50090-4238-2 100 TABLET in a BOTTLE

NDC: 50090-4238-3 30 TABLET in a BOTTLE

NDC: 50090-4238-4 20 TABLET in a BOTTLE

Acetaminophen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313782	acetaminophen 325 MG Oral Tablet	PSN	1
313782	acetaminophen 325 MG Oral Tablet	SCD	1
313782	APAP 325 MG Oral Tablet	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4238-2	2023-01-30	C162847	48780-1	f386c64a-39e8-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Acetaminophen Drug Facts
50090-4238-3	2023-01-30	C162847	48780-1	f386c64a-39e8-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Acetaminophen Drug Facts
50090-4238-4	2023-01-30	C162847	48780-1	f386c64a-39e8-0266-e053-dadaa90a7c1a	Major Pharmaceuticals Acetaminophen Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-4238-2	Acetaminophen	100 in 1 BOTTLE	TABLET	100	1
50090-4238-3	Acetaminophen	30 in 1 BOTTLE	TABLET	30	1
50090-4238-4	Acetaminophen	20 in 1 BOTTLE	TABLET	20	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4238	ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 3 package rows	20201113_da86ccd2-27c9-4f70-b164-e800bc012237.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6719-50	EA - Each	0904-6719	1475eb1d-0b4d-4470-9985-1f4f8a6c9de5	1	2018-12-13
0904-6719-60	EA - Each	0904-6719	6ad17407-abca-48c5-8fc1-b25e9ff15d40	1	2018-12-13
0904-6719-80	EA - Each	0904-6719	3949a6d6-57bb-4d85-bf8c-da4e1f71dd1c	1	2019-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Acetaminophen
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50090-4238	50090-4238-4, 50090-4238-2, 50090-4238-3
0904-6719

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
35571df3-6d56-4238-a5c3-3bce321bdfa5			da86ccd2-27c9-4f70-b164-e800bc012237	2020-11-12	Warnings	Exact identifier spl id: 35571df3-6d56-4238-a5c3-3bce321bdfa5 spl set id: da86ccd2-27c9-4f70-b164-e800bc012237

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.