FDA.reportPublic FDA data

Pain Relief

Manufacturer
Allegiant Health
Effective date
2021-05-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:02:00

Label at a glance#

ProductPain Relief Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections

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 8 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

Storage and handling

store between 20º-25ºC (68º-77ºF)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use(s)

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 4,000mg 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

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

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 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 8 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 information

SPL UNCLASSIFIED SECTION

  • do not use if imprinted safety seal under cap is broken or missing

Storage

STORAGE AND HANDLING SECTION

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch,
purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
*may contain these ingredients

Questions

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain ReliefPain Relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-426-05Pain ReliefExtra Strength500 in 1 BOTTLECAPSULE, COATED5007
69168-426-24Pain ReliefExtra Strength1 in 1 CARTONCAPSULE, COATED17
69168-426-24Pain ReliefExtra Strength24 in 1 BOTTLECAPSULE, COATED247
69168-426-32Pain ReliefExtra Strength100 in 1 BOTTLECAPSULE, COATED1007
69168-426-40Pain ReliefExtra Strength40 in 1 BOTTLECAPSULE, COATED407
69168-426-40Pain ReliefExtra Strength1 in 1 CARTONCAPSULE, COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-426PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN 500MG) CAPSULE, COATED [ALLEGIANT HEALTH]7Current NDC, Legacy NDC, 6 package rows20231115_0f72be92-fac0-4be4-87a3-3f20f0f01db5.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-42669168-426-05, 69168-426-40, 69168-426-24, 69168-426-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POVIDONE K30U725QWY32XIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STARCH, CORNO8232NY3SJCNTM
TITANIUM DIOXIDE15FIX9V2JPCNTM
WATER059QF0KO0RCNTM

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 StrengthACETAMINOPHEN 500MGAllegiant Health0f72be92-fac0-4be4-87a3-3f20f0f01db52021-05-17WarningsExact identifier
ndc (package): 69168-426-32
ndc (package): 69168-426-24
ndc (package): 69168-426-40
ndc (package): 69168-426-05
ndc (product): 69168-426
ndc11 (package): 69168042640
ndc11 (package): 69168042624
ndc11 (package): 69168042605
ndc11 (package): 69168042632
spl id: c63a3602-871f-4cfe-9af5-aa8192dae33b
spl set id: 0f72be92-fac0-4be4-87a3-3f20f0f01db5

Reported adverse events (FAERS/openFDA)#

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