Headache, Circle K™

Headache, Circle K™
SPL v3
SPL
SPL Set ID e711ff0a-2fa0-1f2a-e053-2a95a90a4e38
Route
ORAL
Published
Effective Date 2021-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Cellulose, Microcrystalline Hypromellose, Unspecified Polyethylene Glycol, Unspecified Povidone K30 Silicon Dioxide Starch, Corn Stearic Acid Talc

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-17

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Purpose

Purposes Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Purposes Pain reliever Pain reliever Pain reliever aid

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin (NSAID*) 250 mg Caffeine 65 mg *nonsteroidal anti-inflammatory drug

Uses

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5

Product manufactured for:

Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404

www.lildrugstore.com 54383C-US-08-21



Proudly distributed by Circle K Stores Inc.



*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

Section 50565-1

Keep out of reach of children. 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.

Section 53414-9

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.

Purposes

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Directions

Directions

  • do not use more than directed
  • drink a full glass of water with each dose

adults and children

(12 years and over)

take 2 capletsevery 6 hours as needed;

not more than 8 caplets in 24 hours

children under 12 years ask a doctor

Pdp/package

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

6 caplets (2 per pouch)

Allergy Alert

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.

Reye's Syndrome

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.

Other Information

Other information

  • store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg
Active Ingredients

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

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

Questions Or Comments?

Questions or comments?

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

Stomach Bleeding Warning

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

  • are age 60 or olde
  • have had stomach ulcers or bleeding problems
  • 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


Structured Label Content

Uses

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5 (42229-5)

Product manufactured for:

Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404

www.lildrugstore.com 54383C-US-08-21



Proudly distributed by Circle K Stores Inc.



*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength.

Section 50565-1 (50565-1)

Keep out of reach of children. 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.

Section 53414-9 (53414-9)

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.

Purposes

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Directions

Directions

  • do not use more than directed
  • drink a full glass of water with each dose

adults and children

(12 years and over)

take 2 capletsevery 6 hours as needed;

not more than 8 caplets in 24 hours

children under 12 years ask a doctor

Pdp/package (PDP/Package)

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

6 caplets (2 per pouch)

Allergy Alert (Allergy alert)

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.

Reye's Syndrome (Reye's syndrome)

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.

Other Information (Other information)

Other information

  • store at 68°-77°F (20°-25°C); excursions permitted between 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • each caplet contains: Magnesium 0.58 mg
Active Ingredients (Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID*) 250 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Questions or comments?

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

Stomach Bleeding Warning (Stomach bleeding warning)

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

  • are age 60 or olde
  • have had stomach ulcers or bleeding problems
  • 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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)