FDA.reportPublic FDA data

Pain Relief

Manufacturer
BETTER LIVING BRANDS LLC. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-07-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:40

Label at a glance#

ProductPain Relief
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

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.

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE 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.

DOSAGE & ADMINISTRATION SECTION

Directions

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 take for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

OTHER SAFETY INFORMATION

Other information

  • SODIUM FREE
  • store between 20-25°C (68-77°F) excursions permitted between 15-30°C (59-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients

hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide

*may contain this ingredient

OTC - QUESTIONS SECTION

Questions or comments? 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

341R-Albertsons-Pain Relief-500s-Label341R-Albertsons-Pain Relief-500s-Label

341R-Albertsons-Pain Relief-250s-Label341R-Albertsons-Pain Relief-250s-Label

341R-Albertsons-Pain Relief-250s-Carton341R-Albertsons-Pain Relief-250s-Carton

341R-Albertsons-Pain Relief-150s-Label341R-Albertsons-Pain Relief-150s-Label

341R-Albertsons-Pain Relief-100s-Label341R-Albertsons-Pain Relief-100s-Label

341R-Albertsons-Pain Relief-100s-Carton341R-Albertsons-Pain Relief-100s-Carton

341R-Albertsons-Pain Relief-50s-Label341R-Albertsons-Pain Relief-50s-Label

341R-Albertsons-Pain Relief-50s-Carton341R-Albertsons-Pain Relief-50s-Carton

341R-Albertsons-Pain Relief-24s-Label341R-Albertsons-Pain Relief-24s-Label

341R-Albertsons-Pain Relief-24s-Carton341R-Albertsons-Pain Relief-24s-Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN4
198440acetaminophen 500 MG Oral TabletSCD4
198440APAP 500 MG Oral TabletSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21130-431-012025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-052025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-152025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-252025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-422025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-502025-02-12C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-012025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-052025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-152025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-252025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-422025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg
21130-431-502025-01-30C16284748780-12cef2736-5e37-d83d-e063-dadaa90ab31f341R_Albertsons_21130-431_ACETAMINOPHEN CAPLETS 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-431-01Pain Relief1 in 1 CARTONTABLET14
21130-431-01Pain Relief100 in 1 BOTTLETABLET1004
21130-431-05Pain Relief1 in 1 CARTONTABLET14
21130-431-05Pain Relief50 in 1 BOTTLETABLET504
21130-431-15Pain Relief150 in 1 BOTTLETABLET1504
21130-431-25Pain Relief250 in 1 BOTTLETABLET2504
21130-431-25Pain Relief1 in 1 CARTONTABLET14
21130-431-42Pain Relief24 in 1 BOTTLETABLET244
21130-431-42Pain Relief1 in 1 CARTONTABLET14
21130-431-50Pain Relief500 in 1 BOTTLETABLET5004

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-43121130-431-42, 21130-431-50, 21130-431-15, 21130-431-25, 21130-431-05, 21130-431-01

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
NameUNIIKind
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ACETAMINOPHEN362O9ITL9DACTIB
MINERAL OILT5L8T28FGPIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
ndc (package): 21130-431-25
ndc (package): 21130-431-15
ndc (package): 21130-431-01
ndc (package): 21130-431-50
ndc (package): 21130-431-42
ndc (package): 21130-431-05
ndc (product): 21130-431
ndc11 (package): 21130043101
ndc11 (package): 21130043125
ndc11 (package): 21130043105
ndc11 (package): 21130043150
ndc11 (package): 21130043142
ndc11 (package): 21130043115
spl id: 3a0b3c00-eacb-ff6f-e063-6394a90a70d7
spl set id: f3005d0c-424e-0ab3-e053-2995a90a1c10

Reported adverse events (FAERS/openFDA)#

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