Daytime Cold & Flu, Circle K ™

Daytime Cold & Flu, Circle K ™
SPL v8
SPL
SPL Set ID 55662ada-677e-4048-9529-5bca44076316
Route
ORAL
Published
Effective Date 2021-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sorbitol Sucralose Xanthan Gum Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-08-07 Until 2024-10-14

Description

Drug Facts


Medication Information

Description

Drug Facts

Pdp

TEMPORARILY RELIEVES

ACHES, FEVER, SORE THROAT,

CONGESTION, COUGH

Compare to the

active ingredients

in Vicks ® DayQuil™ Cold & Flu*

CIRCLE K™

daytime

cold & flu

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg,

Phenylephrine HCI 5 mg

Pain Reliever/Fever Reducer,

Cough Suppressant,

Nasal Decongestant

8 fl oz (237 mL)

Uses
  • temporarily relieves common cold and flu symptoms
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • sinus pressure
    • cough due to minor throat and bronchial irritation
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product, do not exceed recommended dosage.

Section 50568-5

Ask a doctor or pharmacist 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.

Section 55105-1
Active ingredients (in each 15 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Warnings

Warnings

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
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 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.
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:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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 15 mL contains: sodium 12 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

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

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

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 237 Ml Bottle Label

Compare to the Active Ingredients in Vicks® DayQuil®*

CIRCLE K

Daytime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl



Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Relieves



- Aches - Sore Throat - Fever



- Nasal Congestion - Cough

Original

8 FL OZ (237mL)


Structured Label Content

Pdp (PDP)

TEMPORARILY RELIEVES

ACHES, FEVER, SORE THROAT,

CONGESTION, COUGH

Compare to the

active ingredients

in Vicks ® DayQuil™ Cold & Flu*

CIRCLE K™

daytime

cold & flu

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg,

Phenylephrine HCI 5 mg

Pain Reliever/Fever Reducer,

Cough Suppressant,

Nasal Decongestant

8 fl oz (237 mL)

Uses
  • temporarily relieves common cold and flu symptoms
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • sinus pressure
    • 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 50567-7 (50567-7)

When using this product, do not exceed recommended dosage.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist 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.

Section 55105-1 (55105-1)
Active ingredients (in each 15 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Warnings

Warnings

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in any 24-hour period
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
adults and children 12 years and over 30 mL every 4 hours
children 6 to under 12 years 15 mL every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
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 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.
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:

  • adult takes more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
  • child takes more than 4 doses (15 mL each) in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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 15 mL contains: sodium 12 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)

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Principal Display Panel 237 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label)

Compare to the Active Ingredients in Vicks® DayQuil®*

CIRCLE K

Daytime Cold & Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl



Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Relieves



- Aches - Sore Throat - Fever



- Nasal Congestion - Cough

Original

8 FL OZ (237mL)


Advanced Ingredient Data


Raw Label Data

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