FDA.reportPublic FDA data

Circle K Pain Reliever

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:32

Label at a glance#

ProductCircle K Pain Reliever Extra Strength
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and 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

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets 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 ask a doctor

Storage and handling

do not use if inner pouch or carton is open or damaged store at room temperature 59-86˚F (15-30˚C) see bottom panel for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

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

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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.

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

  • 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

Ask a doctor before use if 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.

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

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) may cause liver damage. 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 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not use if inner pouch or carton is open or damaged
  • store at room temperature 59-86˚F (15-30˚C)
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, maltodextrin 1, microcrystalline cellulose 1, polyethylene glycol, povidone 1, pregelatinized starch 1, sodium starch glycolate 1, stearic acid, titanium dioxide 1

1 may contain

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)

SPL UNCLASSIFIED SECTION

Proudly distributed by Circle K Stores Inc.

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5733

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CIRCLE K ®

Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer

Extra Strength

ACTUAL SIZE

6 Tablets
3 POUCHES, 2 TABLETS PER POUCH

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5733
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5733

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5633

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

CIRCLE K ®

Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer

Extra Strength

ACTUAL SIZE

6 Tablets
3 POUCHES, 2 TABLETS PER POUCH

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5633
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5633

PDP/Package - NDC 66715-5533

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TEMPORARILY RELIEVES MINOR ACHES & PAINS
Compare to the active ingredient in
Tylenol® Extra Strength**

CIRCLE K™

extra strength
pain reliever
Acetaminophen 500 mg,
Pain Reliever/Fever Reducer

[tablet image]

actual size

6 tablets (2 per pouch)

Carton PDP/PackageCarton PDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN6
198440acetaminophen 500 MG Oral TabletSCD6
198440APAP 500 MG Oral TabletSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5533-3Circle K Pain RelieverExtra Strength2 in 1 POUCHTABLET26
66715-5533-3Circle K Pain RelieverExtra Strength3 in 1 CARTONTABLET36
66715-5633-3Circle K Pain RelieverExtra Strength2 in 1 POUCHTABLET26
66715-5633-3Circle K Pain RelieverExtra Strength3 in 1 CARTONTABLET36
66715-5733-3Circle K Pain RelieverExtra Strength2 in 1 POUCHTABLET26
66715-5733-3Circle K Pain RelieverExtra Strength3 in 1 CARTONTABLET36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5533CIRCLE K PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Current NDC, Legacy NDC, 2 package rows20231215_f2359bc3-901f-4ecb-b402-cb2fe404a935.zip
66715-5633CIRCLE K PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Legacy NDC, 2 package rows20231215_f2359bc3-901f-4ecb-b402-cb2fe404a935.zip
66715-5733CIRCLE K PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [LIL' DRUG STORE PRODUCTS, INC.]6Legacy NDC, 2 package rows20231215_f2359bc3-901f-4ecb-b402-cb2fe404a935.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
66715-573366715-5733-3
66715-563366715-5633-3
66715-553366715-5533-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
ndc (package): 66715-5733-3
ndc (package): 66715-5533-3
ndc (package): 66715-5633-3
ndc (product): 66715-5733
ndc (product): 66715-5633
ndc (product): 66715-5533
ndc11 (package): 66715573303
ndc11 (package): 66715553303
ndc11 (package): 66715563303
spl id: 0c7ed4df-8e3b-7b4f-e063-6294a90a494c
spl set id: f2359bc3-901f-4ecb-b402-cb2fe404a935

Reported adverse events (FAERS/openFDA)#

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