Label at a glance#

ProductPain Reliever Extra Strength

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-426-9391

Websitewww.fredsinc.com

www.fredsinc.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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
the common cold
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 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

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

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
adults and children 12 years and over

take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours, unless directed by a doctor
do not take 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, povidone, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fred's
Pharmacy

NDC 55315-148-12

Compare to the active ingredient in:
Extra Strength Tylenol^®*

Extra Strength
PAIN RELIEVER

ACETAMINOPHEN 500 mg
Pain Reliever/Fever Reducer

100 TABLETS

Contains no aspirin

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Extra Strength Tylenol^®.

50844 ORG061714812

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
guaranteed
Questions or comments: 1-855-331-FRED (3733)

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Pain Reliever Extra Strength
Acetaminophen
STARCH, CORN
POVIDONE, UNSPECIFIED
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55315-148	55315-148-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	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
77d2c082-9893-4a98-bed9-d353947429ba			78bd79d7-1871-47c2-9dcb-df97add83ef7	2020-06-12	Warnings	Exact identifier spl id: 77d2c082-9893-4a98-bed9-d353947429ba spl set id: 78bd79d7-1871-47c2-9dcb-df97add83ef7

Reported adverse events (FAERS/openFDA)#

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