Circle K Pain Reliever
FDA Label NDC 66715-5633

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Circle K Pain Reliever (NDC 66715-5633). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, liver warning, do not use, otc - ask doctor, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

    Proudly distributed by Circle K Stores Inc.

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

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.

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

Otc - Ask Doctor

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

  • 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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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 yearsask a doctor

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)

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

Principal Display Panel (500 mg Tablet Pouch Carton)

Principal Display Panel (500 mg Tablet Pouch Carton)

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)

Principal Display Panel (500 mg Tablet Pouch Carton)

* Please review the disclaimer below.