FDA.reportPublic FDA data

Pain Relief

Manufacturer
Allegiant Health
Effective date
2021-11-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:03

Label at a glance#

ProductPain Relief Extra Strength
Active ingredientACETAMINOPHEN
Label structure8 sections

Dosage and administration

■ do not use 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 8 caplets in 24 hours unless directed by a doctor  ■  Do not use more than 10 days unless directed by a doctor   ■ children under 12 years:  ask a doctor 

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use(s)

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains associated with   ■ common cold   ■ headache    ■  toothache 

■ muscular aches  ■ backache     ■ arthritis    ■ menstrual cramps    ■ and reduction of fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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

OTC - ASK DOCTOR SECTION

you have liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are 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

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contact a Poison Control Center right away.
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 use 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 8 caplets in 24 hours unless directed by a doctor 

■  Do not use more than 10 days unless directed by a doctor  

■ children under 12 years: ask a doctor 

Other information

SPL UNCLASSIFIED SECTION

  • store between 20º-25ºC (68º-77ºF)

  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain ReliefPain ReliefPain ReliefPain Relief

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
69168-005-40Pain ReliefExtra Strength40 in 1 BOTTLETABLET403
69168-005-40Pain ReliefExtra Strength1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-005PAIN RELIEF EXTRA STRENGTH (PAIN RELIEF) TABLET [ALLEGIANT HEALTH]3Current NDC, Legacy NDC, 2 package rows20231020_d41d2319-8eed-4df9-813c-313497ceb8b4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-00569168-005-40

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
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

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 Relief Extra StrengthPAIN RELIEFAllegiant Healthd41d2319-8eed-4df9-813c-313497ceb8b42021-11-23WarningsExact identifier
ndc (package): 69168-005-40
ndc (product): 69168-005
ndc11 (package): 69168000540
spl id: 88c123d3-f75c-4305-b47f-e5398ac27959
spl set id: d41d2319-8eed-4df9-813c-313497ceb8b4

Reported adverse events (FAERS/openFDA)#

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