Label at a glance#

ProductNon-Aspirin

Active ingredientAcetaminophen

Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache arthritis the common cold toothache 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 as needed do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause...

Storage and handling

do not use if imprinted safety seal under cap is broken or missing. store between 20-25 ° C (68-77 ° F) see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever/fever reducer

Warnings

WARNINGS SECTION

Liver Warning:

WARNINGS SECTION

this product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets in 24 hours, which is the maxium daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days

These could be sign 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

Enter section text here

Overdose warning:

OVERDOSAGE SECTION

Taking more than the recommended dose(overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 as needed do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor
children under 12 years	do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information

STORAGE AND HANDLING SECTION

do not use if imprinted safety seal under cap is broken or missing.

store between 20-25°C (68-77°F)
see end panel for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

non-aspirin 50 tabletimage of carton label

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
arthritis
the common cold
toothache
menstrual cramps
temporarily reduces fever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	1
198440	acetaminophen 500 MG Oral Tablet	SCD	1
198440	APAP 500 MG Oral Tablet	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43459-0152-6	2019-10-21	C162847	48780-1	956f9ecf-c5be-621f-e053-dbdaa90a74ad	Drug Facts
43459-0153-6	2019-10-21	C162847	48780-1	956f9ecf-c5be-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43459-0152-6	Non-Aspirin	1 in 1 BOX	TABLET	1	1
43459-0152-6	Non-Aspirin	40 in 1 BOTTLE	TABLET	40	1
43459-0153-6	Non-Aspirin	50 in 1 BOTTLE	TABLET	50	1
43459-0153-6	Non-Aspirin	1 in 1 BOX	TABLET	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43459-0152	NON-ASPIRIN (ACETAMINOPHEN) TABLET [ETEX PHARM CO., LTD]	1	Legacy NDC, 2 package rows	20100805_e1ca0b60-0477-4b41-811f-82426d0849d6.zip
43459-0153	NON-ASPIRIN (ACETAMINOPHEN) TABLET [ETEX PHARM CO., LTD]	1	Legacy NDC, 2 package rows	20100805_e1ca0b60-0477-4b41-811f-82426d0849d6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

Non-Aspirin
Acetaminophen

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43459-0153	43459-0153-6
43459-0152	43459-0152-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
Acetaminophen	362O9ITL9D	ACTIB

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
9b0c0db2-168f-45b3-a2ce-b9204dcccd32			e1ca0b60-0477-4b41-811f-82426d0849d6	2010-06-30	Warnings	Exact identifier spl id: 9b0c0db2-168f-45b3-a2ce-b9204dcccd32 spl set id: e1ca0b60-0477-4b41-811f-82426d0849d6

Reported adverse events (FAERS/openFDA)#

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