acetaminophen

Manufacturer: Rite Aid Corporation
Effective date: 2025-10-09
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:38:36

Label at a glance#

Productacetaminophen

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • 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 caplets every 6 hours while symptoms last • do not take more than 6 caplets 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

Storage and handling

• store at 20-25°C (68-77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

more than 4,000 mg of acetaminophen in 24 hours
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.

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 have ever had an allergic reaction to this product or any of its ingredients

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

pain gets worse or lasts more than 10 days
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 caplets every 6 hours while symptoms last do not take more than 6 caplets 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 information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Extra Strength Tylenol^® Caplets

FREE FROM

GLUTEN FREE

CAFFEINE FREE

EXTRA STRENGTH

ACETAMINOPHEN

ACETAMINOPHEN CAPLETS, 500 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER

For adults

100 CAPLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	6
198440	acetaminophen 500 MG Oral Tablet	SCD	6
198440	APAP 500 MG Oral Tablet	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11822-4484-1	acetaminophen	1 in 1 CARTON	TABLET	1	6
11822-4484-1	acetaminophen	225 in 1 BOTTLE	TABLET	225	6
11822-4484-2	acetaminophen	1000 in 1 BOTTLE	TABLET	1000	6
11822-4484-3	acetaminophen	24 in 1 BOTTLE	TABLET	24	6
11822-4484-3	acetaminophen	1 in 1 CARTON	TABLET	1	6
11822-4484-4	acetaminophen	50 in 1 BOTTLE	TABLET	50	6
11822-4484-4	acetaminophen	1 in 1 CARTON	TABLET	1	6
11822-4484-5	acetaminophen	1 in 1 CARTON	TABLET	1	6
11822-4484-5	acetaminophen	100 in 1 BOTTLE	TABLET	100	6
11822-4484-6	acetaminophen	500 in 1 BOTTLE	TABLET	500	6

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

acetaminophen
CARNAUBA WAX
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11822-4484	11822-4484-1, 11822-4484-2, 11822-4484-3, 11822-4484-4, 11822-4484-5, 11822-4484-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
5	2024-11-12	full-release	2026-06-01 00:37:32

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
acetaminophen	ACETAMINOPHEN	Rite Aid Corporation	a8bb4f45-7a1a-4bf7-92ca-3afd508032f3	2025-10-09	Warnings	Exact identifier ndc (package): 11822-4484-4 ndc (package): 11822-4484-6 ndc (package): 11822-4484-2 ndc (package): 11822-4484-1 ndc (package): 11822-4484-5 ndc (package): 11822-4484-3 ndc (product): 11822-4484 ndc11 (package): 11822448401 ndc11 (package): 11822448402 ndc11 (package): 11822448403 ndc11 (package): 11822448405 ndc11 (package): 11822448404 ndc11 (package): 11822448406 spl id: 063fe4f3-5ef2-4c8b-a8a5-7adeab4dde00 spl set id: a8bb4f45-7a1a-4bf7-92ca-3afd508032f3

Reported adverse events (FAERS/openFDA)#

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