Circle K ®

Circle K ®
SPL v6
SPL
SPL Set ID f2359bc3-901f-4ecb-b402-cb2fe404a935
Route
ORAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromellose, Unspecified Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Corn Stearic Acid Titanium Dioxide Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: AZ;235 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-01 Until 2024-05-20

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50569-3

Ask a doctor before use if you have liver disease

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • 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
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
Liver Warning

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.
Overdose Warning

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.

Other Information
  • 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

corn starch, hypromellose, maltodextrin

may contain
, microcrystalline cellulose
, polyethylene glycol, povidone
, pregelatinized starch
, sodium starch glycolate
, stearic acid, titanium dioxide

Questions Or Comments?

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

Pdp/package Ndc 66715 5533

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)

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.

Active Ingredient (in Each Tablet)

Acetaminophen 500 mg

Principal Display Panel 500 Mg Tablet Pouch Carton 66715 5633

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

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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Directions
  • 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
Do Not Use (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
Liver Warning (Liver warning)

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.
Overdose Warning (Overdose warning)

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.

Other Information (Other information)
  • 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 ingredients)

corn starch, hypromellose, maltodextrin

may contain
, microcrystalline cellulose
, polyethylene glycol, povidone
, pregelatinized starch
, sodium starch glycolate
, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Pdp/package Ndc 66715 5533 (PDP/Package - NDC 66715-5533)

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)

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 500 mg

Principal Display Panel 500 Mg Tablet Pouch Carton 66715 5633 (PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Carton - 66715-5633)

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)

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


Advanced Ingredient Data


Raw Label Data

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