Extra Strength Headache

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:50:10

Label at a glance#

ProductExtra Strength Headache, Circle K
Active ingredientASPIRIN, CAFFEINE, ACETAMINOPHEN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever

Pain reliever

Pain reliever aid

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps

WARNINGS SECTION

Reye's Syndrome

SPL UNCLASSIFIED SECTION

Reye’s syndrome: Children and teenagers who have or are
recovering from chicken pox or flu-like symptoms should not
use this product. When using this product, if changes in
behavior with nausea and vomiting occur, consult a doctor
because these symptoms could be an early sign of Reye's
syndrome, a rare but serious illness.

Allergy Alert

SPL UNCLASSIFIED SECTION

Allergy alert:Aspirin may cause a severe allergic reaction,
which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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.

Liver Warning

SPL UNCLASSIFIED SECTION

Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take: • more than 8 caplets
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

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The
chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Caffeine warning

SPL UNCLASSIFIED SECTION

Caffeine warning: The recommended dose of this product
contains about as much caffeine as a cup of coffee. Limit
the use of caffeine-containing medications, foods, or
beverages while taking this product because too much
caffeine may cause nervousness, irritability, sleeplessness,
and, occasionally, rapid heartbeat.

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

  • any other drug containing an NSAID (prescription or nonprescription)
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug or are under a doctor’s care for any serious condition
  • a blood thinning (anticoagulant) or steroid drug

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms appear

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. It is especially important not to use aspirin
during the last 3 months of pregnancy unless definitely
directed to do so by a doctor because it may cause problems
in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Overdose warning: In case of overdose, get medical help
or contact a Poison Control 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not use more than directed (see Overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; do not take more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store between 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

OTC - QUESTIONS SECTION

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

PDP (Lil' Drug)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[caduceus]

Compare to the Active
Ingredients in Excedrin®
Extra Strength**

Extra Strength
Headache

Acetaminophen 250 mg
Pain Reliever
Aspirin (NSAID) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50

Caplets [Lil' Drug Store Logo]

PDPPDP

PDP (CK)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TEMPORARILY RELIEVES
HEADACHES

Compare to the active ingredients
in Excedrin ® Extra Strength*

CIRCLE K™

extra strength
headache

Acetaminophen 250 mg, Pain Reliever
Aspirin (NSAID) 250 mg, Pain Reliever
Caffeine 65 mg, Pain Reliever Aid

[caplet image]

actual size

50 caplets

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN5
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD5
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-5506-4Extra Strength Headache, Circle K1 in 1 CARTONTABLET15
66715-5506-4Extra Strength Headache, Circle K50 in 1 BOTTLE, PLASTICTABLET505
66715-6922-4Extra Strength Headache1 in 1 CARTONTABLET15
66715-6922-4Extra Strength Headache50 in 1 BOTTLE, PLASTICTABLET505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-5506EXTRA STRENGTH HEADACHE, CIRCLE K (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET EXTRA STRENGTH HEADACHE (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]5Current NDC, Legacy NDC, 2 package rows20250101_d18e1631-de43-4b29-e053-2995a90af56d.zip
66715-6922EXTRA STRENGTH HEADACHE, CIRCLE K (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET EXTRA STRENGTH HEADACHE (ACETAMINOPHEN/ASPIRIN/CAFFEINE TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC.]5Current NDC, Legacy NDC, 2 package rows20250101_d18e1631-de43-4b29-e053-2995a90af56d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-550666715-5506-4
68210-4094
66715-692266715-6922-4
68210-0107

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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 Headache, Circle KACETAMINOPHEN/ASPIRIN/CAFFEINE TABLETLil' Drug Store Products, Inc.d18e1631-de43-4b29-e053-2995a90af56d2024-12-31WarningsExact identifier
ndc (package): 66715-6922-4
ndc (package): 66715-5506-4
ndc (product): 66715-6922
ndc (product): 66715-5506
ndc11 (package): 66715692204
ndc11 (package): 66715550604
spl id: 2a91d0c9-4de2-fc80-e063-6294a90a6cb9
spl set id: d18e1631-de43-4b29-e053-2995a90af56d

Reported adverse events (FAERS/openFDA)#

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