Non-drowsy Max Cold, Circle K™

Non-drowsy Max Cold, Circle K™
SPL v2
SPL
SPL Set ID e79f1a92-d8ea-e3f9-e053-2a95a90a2d37
Route
ORAL
Published
Effective Date 2022-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Povidone, Unspecified Sucralose Talc Stearic Acid Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Titanium Dioxide Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Starch, Corn Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: 44;470 Shape: oval Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Description

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCI 5 mg

Uses

Uses

  • temporary relieves these common cold and flu symptoms:
  • minor aches and pains
  • nasal congestion
  • headache
  • cough
  • sinus congestion and pressure
  • sore throat
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever
Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

Stop Use

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion 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 is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
  • 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 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Pdp/package

TEMPORARILY RELIEVES COLD/FLU SYMPTOMS

Compare to the active ingredients in

Tylenol® Cold Max*

CIRCLE K™

non-drowsy

max cold

Acetaminophen, Dextromethorphan HBr,

Phenylephrine HCI

Pain Reliever/Fever Reducer,

Cough Suppressant,

Nasal Decongestant

[caplet image]

actual size

6 caplets

Ask A Doctor

Ask a doctor before use if you have

  • thyroid disease
  • high blood pressure
  • liver disease
  • heart disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Allergy Alert

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away. 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.

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
Other Information

Other information

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number
Active Ingredients

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Inactive Ingredients

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?

Questions or comments?

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

Tamper Evident Statement

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING


Structured Label Content

Uses

Uses

  • temporary relieves these common cold and flu symptoms:
  • minor aches and pains
  • nasal congestion
  • headache
  • cough
  • sinus congestion and pressure
  • sore throat
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

Purpose

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Stop Use (Stop use)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion 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 is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
Directions

Directions

  • do not take more than directed
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor
Do Not Use (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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
Pdp/package (PDP/Package)

TEMPORARILY RELIEVES COLD/FLU SYMPTOMS

Compare to the active ingredients in

Tylenol® Cold Max*

CIRCLE K™

non-drowsy

max cold

Acetaminophen, Dextromethorphan HBr,

Phenylephrine HCI

Pain Reliever/Fever Reducer,

Cough Suppressant,

Nasal Decongestant

[caplet image]

actual size

6 caplets

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you have

  • thyroid disease
  • high blood pressure
  • liver disease
  • heart disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)
Allergy Alert (Allergy alert)

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away. 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.

Liver Warning (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
Other Information (Other information)

Other information

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number
Active Ingredients (Active ingredients)

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCI 5 mg

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Questions or comments?

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

Tamper Evident Statement (Tamper evident statement)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING


Advanced Ingredient Data


Raw Label Data

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