FDA.reportPublic FDA data

Pain Relief

Manufacturer
Allegiant Health
Effective date
2020-03-13
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:02:03

Label at a glance#

ProductPain Relief Extra Strength
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

temporary relief of minor aches and pains associated with   ■ the common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ minor pain from arthritis   ■ premenstrual  and menstrual cramps   ■ temporarily reduces fever

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 6 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: Consult a doctor

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pains associated with   ■ the common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ minor pain from arthritis  

■ premenstrual  and menstrual cramps   ■ temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take n more than 4,000mg
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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

If pregnant or breastfeeding

SPL UNCLASSIFIED 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 (1-800-222-1222) 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 6 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: Consult 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

SPL UNCLASSIFIED SECTION

Call 1-888-952-0050 Monday to Friday 9am-5pm EST

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Health A2Z®

Compare to Tylenol® active ingredient*

See New Warnings Information

Extra Strength
PAIN RELIEF
Acetaminophen
Pain Reliever-Fever Reducer
CONTAINS NO ASPIRIN

500 mg
Pain ReliefPain Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN10
198440acetaminophen 500 MG Oral TabletSCD10
198440APAP 500 MG Oral TabletSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69168-328-012020-12-07C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-032020-12-07C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-132020-12-07C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-402020-12-07C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-012020-01-31C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-032020-01-31C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-132020-01-31C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts
69168-328-402020-01-31C16284748780-19d75b9d0-6c01-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-328-01Pain ReliefExtra Strength100 in 1 CARTONTABLET10010
69168-328-03Pain ReliefExtra Strength250 in 1 BOTTLETABLET25010
69168-328-13Pain ReliefExtra Strength175 in 1 BOTTLETABLET17510
69168-328-40Pain ReliefExtra Strength40 in 1 CARTONTABLET4010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-328PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500 MG) TABLET [ALLEGIANT HEALTH]10Current NDC, Legacy NDC, 4 package rows20231115_8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

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
69168-32869168-328-40, 69168-328-01, 69168-328-13, 69168-328-03

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
STEARIC ACID4ELV7Z65APIACT
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates

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 StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
ndc (package): 69168-328-40
ndc (package): 69168-328-03
ndc (package): 69168-328-01
ndc (package): 69168-328-13
ndc (product): 69168-328
ndc11 (package): 69168032803
ndc11 (package): 69168032840
ndc11 (package): 69168032813
ndc11 (package): 69168032801
spl id: 7ed5b51e-f50e-42cd-965e-2962d68ec75f
spl set id: 8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7

Reported adverse events (FAERS/openFDA)#

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