Circle K ™

Circle K ™
SPL v8
SPL
SPL Set ID 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f
Route
ORAL
Published
Effective Date 2021-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Acesulfame Potassium Alcohol Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-11-01 Until 2024-09-15

Description

Drug Facts


Medication Information

Description

Drug Facts

Pdp

TEMPORARILY RELIEVES ACHES, SORE THROAT,

FEVER, SNEEZING, RUNNY NOSE, COUGH


Compare to the active ingredients

in Vicks® NyQuil® Cold & Flu*

CIRCLE K

nighttime

cold & flu

cherry flavor, 10% alcohol

Acetaminophen 650 mg,

Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

Pain Reliever/Fever Reducer, Cough Suppressant,

Antihistamine

8 fl oz (237 mL)

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • runny nose and sneezing
    • fever
    • cough due to minor throat and bronchial irritation
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each 30 mL) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine succinate 12.5 mg Antihistamine
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with the dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Do Not Use
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 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
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 24 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients

acesulfame potassium, alcohol, citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments?

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

When Using This Product
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 237 Ml Bottle Label

Compare to the Active Ingredients in Vicks® NyQuil®*

CIRCLE K

Nighttime Cold & Flu

Acetaminophen 650 mg, Pain Reliever/Fever Reducer

Dextromethorphan HBr 30 mg, Cough Suppressant

Doxylamine Succinate 12.5 mg, Antihistamine

Relieves

  • Aches - Sore Throat - Fever
  • Sneezing - Runny Nose - Cough

10% Alcohol

Cherry

8 FL OZ (237mL)

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Structured Label Content

Pdp (PDP)

TEMPORARILY RELIEVES ACHES, SORE THROAT,

FEVER, SNEEZING, RUNNY NOSE, COUGH


Compare to the active ingredients

in Vicks® NyQuil® Cold & Flu*

CIRCLE K

nighttime

cold & flu

cherry flavor, 10% alcohol

Acetaminophen 650 mg,

Dextromethorphan HBr 30 mg, Doxylamine succinate 12.5 mg

Pain Reliever/Fever Reducer, Cough Suppressant,

Antihistamine

8 fl oz (237 mL)

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • runny nose and sneezing
    • fever
    • cough due to minor throat and bronchial irritation
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 30 mL) Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 30 mg Cough suppressant
Doxylamine succinate 12.5 mg Antihistamine
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with the dosing cup provided. Do not use any other dosing device.
  • mL = milliliter
  • keep dosing cup with product
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years of age: do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Do Not Use (Do not use)
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000 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)
  • each 30 mL contains: potassium 5 mg
  • each 30 mL contains: sodium 24 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, alcohol, citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

Compare to the Active Ingredients in Vicks® NyQuil®*

CIRCLE K

Nighttime Cold & Flu

Acetaminophen 650 mg, Pain Reliever/Fever Reducer

Dextromethorphan HBr 30 mg, Cough Suppressant

Doxylamine Succinate 12.5 mg, Antihistamine

Relieves

  • Aches - Sore Throat - Fever
  • Sneezing - Runny Nose - Cough

10% Alcohol

Cherry

8 FL OZ (237mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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