Circle K ®

Circle K ®
SPL v8
SPL
SPL Set ID b6a46498-d9a8-4da2-9283-57d135f305a5
Route
ORAL
Published
Effective Date 2021-08-25
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 Fd&c Red No. 40 Gelatin, Unspecified Glycerin Lecithin, Soybean Light Mineral Oil Mannitol Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: PC9 Shape: oval Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-08-25 Until 2024-07-13

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 LiquiCaps®**

CIRCLE K

daytime

cold & flu

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg

Pain Reliever/Fever Reducer, Cough Suppressant,

Nasal Decongestant

[softgel image]

actual size

16 softgels*

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • 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 softgel) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 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 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 can 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
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
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

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

Questions Or Comments?

call toll-free 1-877-507-6516

(M-F 8AM-4:30PM CST)

Stop Use and Ask A Doctor If
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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 16 Softgel Blister Pack Carton

Compare to the Active Ingredients in

Vicks® DayQuil® LiquiCaps®**

CIRCLE K ®

Daytime Cold & Flu

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Non-Drowsy Relief of

- Aches - Fever - Sore Throat

- Nasal Congestion - Cough

ACTUAL SIZE

16 Softgels

(Liquid-filled capsules)


Structured Label Content

Pdp (PDP)

TEMPORARILY RELIEVES ACHES, FEVER,

SORE THROAT, CONGESTION, COUGH


Compare to the active ingredients in

Vicks® DayQuil® Cold & Flu LiquiCaps®**

CIRCLE K

daytime

cold & flu

Acetaminophen 325 mg,

Dextromethorphan HBr 10 mg, Phenylephrine HCI 5 mg

Pain Reliever/Fever Reducer, Cough Suppressant,

Nasal Decongestant

[softgel image]

actual size

16 softgels*

Uses
  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • 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 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 softgel) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 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

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 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 can 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)
  • store between 15°-30°C (59°-86°F)
  • avoid excessive heat
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)

FD&C yellow #6, FD&C red #40, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

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)
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • nervousness, dizziness, or sleeplessness occur
  • 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • 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 16 Softgel Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 16 Softgel Blister Pack Carton)

Compare to the Active Ingredients in

Vicks® DayQuil® LiquiCaps®**

CIRCLE K ®

Daytime Cold & Flu

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Nasal Decongestant

Non-Drowsy Relief of

- Aches - Fever - Sore Throat

- Nasal Congestion - Cough

ACTUAL SIZE

16 Softgels

(Liquid-filled capsules)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)