Acetaminophen

Manufacturer: Safrel Pharmaceuticals, LLC.
Effective date: 2021-05-31
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:40:38

Label at a glance#

ProductAcetaminophen

Active ingredientACETAMINOPHEN

Label structure15 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 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 contact1-844-384-3723

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:
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 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

FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-844-384-3723

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Tylenol ^® Extra Strength Rapid Release Gels

Rapid Release Caplets

EXTRA STRENGTH

Acetaminophen

Caplets, 500 mg

Pain reliever, Fever reducer

RAPID RELEASE

Aspirin free

For adults

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

apap red

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	2
198440	acetaminophen 500 MG Oral Tablet	SCD	2
198440	APAP 500 MG Oral Tablet	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71309-078-04	2024-01-30	C162847	48780-1	1030e365-4a21-111a-e063-dadaa90a10e2	Acetaminophen Rapid Release Caplets, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71309-078-04	Acetaminophen	400 in 1 BOTTLE	TABLET, FILM COATED	400		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-078	ACETAMINOPHEN TABLET, FILM COATED [SAFREL PHARMACEUTICALS, LLC.]	2	Legacy NDC, 1 package rows	20210601_a2e88a6e-64b6-6818-e053-2a95a90abd0c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Acetaminophen
SODIUM STARCH GLYCOLATE TYPE A CORN
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE, UNSPECIFIED
STEARIC ACID
FD&C RED NO. 40
FD&C YELLOW NO. 6

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71309-078	71309-078-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
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
c3a56b3e-1815-e747-e053-2995a90ae61f			a2e88a6e-64b6-6818-e053-2a95a90abd0c	2021-05-31	Warnings	Exact identifier spl id: c3a56b3e-1815-e747-e053-2995a90ae61f spl set id: a2e88a6e-64b6-6818-e053-2a95a90abd0c

Reported adverse events (FAERS/openFDA)#

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