Label at a glance#

ProductPain Reliever

Active ingredientACETAMINOPHEN

Label structure16 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 between 20° to 25°C (68° to 77°F) do not use if carton is opened, or printed foil seal under cap is torn or missing.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-855-274-4122

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen USP 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 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

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 between 20° to 25°C (68° to 77°F)
do not use if carton is opened, or printed foil seal under cap is torn or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

OTC - QUESTIONS SECTION

1-855-274-4122

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
Walgreens.com ©2021 Walgreen Co.

MADE IN INDIA

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9947-35

Walgreens

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

SEE NEW WARNINGS INFORMATION & DIRECTIONS

FOR ADULTS
Pain
Reliever
ACETAMINOPHEN 500 mg
PAIN RELIEVER / FEVER REDUCER

Extra Strength

225CAPLETS
500 mg EACH

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg ( 100 Caplets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (225 Caplets Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0363-9947-35

Walgreens

Compare to the active ingredient in
Tylenol ^® Extra strength Caplets ^#

SEE NEW WARNINGS INFORMATION & DIRECTIONS

FOR ADULTS
Pain
Reliever
ACETAMINOPHEN 500MG
PAIN RELIEVER / FEVER REDUCER

Extra Strength
225
CAPLETS
500 mg EACH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	4
198440	acetaminophen 500 MG Oral Tablet	SCD	4
198440	APAP 500 MG Oral Tablet	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-9947-29	Pain Reliever	150 in 1 BOTTLE	TABLET	150	4
0363-9947-35	Pain Reliever	1 in 1 CARTON	TABLET	1	4
0363-9947-35	Pain Reliever	225 in 1 BOTTLE	TABLET	225	4
0363-9947-40	Pain Reliever	500 in 1 BOTTLE	TABLET	500	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9947	PAIN RELIEVER (ACETAMINOPHEN) TABLET [WALGREEN CO.]	4	Current NDC, Legacy NDC, 4 package rows	20231207_cc939a7c-ce56-5dd6-e053-2995a90aa8af.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Pain Reliever
Acetaminophen
POVIDONE K30
STARCH, CORN
PALMITOSTEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0363-9947	0363-9947-29, 0363-9947-35, 0363-9947-40

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
POVIDONE K30	U725QWY32X	IACT
STARCH, CORN	O8232NY3SJ	IACT
PALMITOSTEARIC ACID	Q8Y7S3B85M	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
Pain Reliever	ACETAMINOPHEN	WALGREEN CO.	cc939a7c-ce56-5dd6-e053-2995a90aa8af	2023-12-06	Warnings	Exact identifier ndc (package): 0363-9947-40 ndc (package): 0363-9947-35 ndc (package): 0363-9947-29 ndc (product): 0363-9947 ndc11 (package): 00363994729 ndc11 (package): 00363994740 ndc11 (package): 00363994735 spl id: 0bd295c7-906d-634f-e063-6394a90a8f3e spl set id: cc939a7c-ce56-5dd6-e053-2995a90aa8af

Reported adverse events (FAERS/openFDA)#

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