Pain Relief

Manufacturer
SAFEWAY
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:12

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 tablets 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 Label Information

Other information

store between 20-25°C (68-77°F) retain carton for complete product information

Inactive ingredients

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Signature Care® Quality Guaranteed Compare to Tylenol® Extra Strength Coated Tablets active ingredient* NDC 21130-492-01 EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN, 500 mg Pain Reliever / Fever Reducer •Sweet Coated Actual Size 100 COATED TABLETS

Label Images#

f109201sig_r1
f109201sig_r1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN3
198440acetaminophen 500 MG Oral TabletSCD3
198440APAP 500 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-492-01Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003
21130-492-01Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-492PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAFEWAY]3Current NDC, 2 package rows20241204_d2d15e06-e9eb-3d2b-e053-2995a90a1cec.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-49221130-492-01

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 tablets 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 20-25°C (68-77°F) retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Signature Care® Quality Guaranteed Compare to Tylenol® Extra Strength Coated Tablets active ingredient* NDC 21130-492-01 EXTRA STRENGTH PAIN RELIEF ACETAMINOPHEN, 500 mg Pain Reliever / Fever Reducer •Sweet Coated Actual Size 100 COATED TABLETS

Source Document#

Source XML