FDA.reportPublic FDA data

Extra Strength Pain Reliever, Caseys 4good

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:04

Label at a glance#

ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and 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

Dosage and administration

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

Storage and handling

Other information store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen USP 500 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Uses

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

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

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.

Overdose warning

OVERDOSAGE SECTION

Overdose warning: In case of overdose, get 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.

Directions

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

Other information

STORAGE AND HANDLING SECTION

Other information

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients povidone, pregelatinized starch (maize), stearic acid

Questions

OTC - QUESTIONS SECTION

Questions or comments?
Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

SPL UNCLASSIFIED SECTION

**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.

Extra Strength Pain Reliever, Lil' Drug Store, 50ct PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[caduceus]

Compare to the Active
Ingredient in Tylenol®
Extra Strength Caplets**

Extra Strength
Pain Reliever

Acetaminophen 500 mg
Pain Reliever/Fever Reducer

[caplet image]

ACTUAL SIZE

50Caplets

[Lil' Drug Store logo]

PDP/PackagePDP/Package

Extra Strength Pain Reliever, Casey's 4good, 50ct PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Pain Reliever

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Compare to the

active ingredient

in Tylenol® Extra

Strength*

[caplet image]

actual

size

[ Casey's 4good logo TM]

50 CAPLETS

PDP/PackagePDP/Package

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
66715-6321-4Extra Strength Pain Reliever, Caseys 4good1 in 1 CARTONTABLET, FILM COATED13
66715-6321-4Extra Strength Pain Reliever, Caseys 4good50 in 1 BOTTLE, PLASTICTABLET, FILM COATED503
66715-6871-4Pain Reliever50 in 1 BOTTLE, PLASTICTABLET, FILM COATED503
66715-6871-4Pain Reliever1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6321PAIN RELIEVER (ACETAMINOPHEN 500MG, FILM-COATED CAPLET) TABLET, FILM COATED EXTRA STRENGTH PAIN RELIEVER, CASEYS 4GOOD (ACETAMINOPHEN 500MG, FILM-COATED CAPLET) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, 2 package rows20241218_e5fc5340-c224-e02b-e053-2a95a90a5297.zip
66715-6871PAIN RELIEVER (ACETAMINOPHEN 500MG, FILM-COATED CAPLET) TABLET, FILM COATED EXTRA STRENGTH PAIN RELIEVER, CASEYS 4GOOD (ACETAMINOPHEN 500MG, FILM-COATED CAPLET) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20241218_e5fc5340-c224-e02b-e053-2a95a90a5297.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
66715-687166715-6871-4
66715-632166715-6321-4

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
POVIDONE K30U725QWY32XIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
PALMITOSTEARIC ACIDQ8Y7S3B85MIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
PALMITOSTEARIC ACIDQ8Y7S3B85MIACT
POVIDONE K30U725QWY32XIACT

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
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
ndc (package): 66715-6321-4
ndc (package): 66715-6871-4
ndc (product): 66715-6871
ndc (product): 66715-6321
ndc11 (package): 66715632104
ndc11 (package): 66715687104
spl id: 2969c6e6-7fee-195e-e063-6294a90a268f
spl set id: e5fc5340-c224-e02b-e053-2a95a90a5297

Reported adverse events (FAERS/openFDA)#

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