Cold-eeze®

Cold-eeze®
SPL v1
SPL
SPL Set ID e68e3480-0e4d-4fa5-8840-91207034f5f0
Route
ORAL
Published
Effective Date 2016-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 20 mL) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Directions
  • do not take more than directed

    (see Overdose warning)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • Adults and children 12 years and older: 20 mL orally every 4 hours, not to exceed 6 doses in 24 hours.
  • Children under 12 years of age: Do not use unless directed by a doctor
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.
  • for children under 12 years of age
  • 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.
Questions?

1-800-505- 2653

(M-F: 9AM-5PM EST)


You may also report side effects to this phone number

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 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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 right away (1-800-222-1222). 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 20 mL contains:

    sodium 12 mg
  • tamper evident: do not use if foil seal under bottle cap is open or missing
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

When Using This Product
  • do not use more than directed
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
  • 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 persistent headache. 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, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If
  • you are taking the blood thinning drug warfarin
Principal Display Panel 266 Ml Bottle Label

MAXIMUM STRENGTH

Cold-EEZE®

Daytime Cold & Flu

Acetaminophen 650 mg • Pain Reliever/Fever Reducer

Phenylephrine HCl 10 mg • Nasal Decongestant

Dextromethorphan HBr 20 mg • Cough Suppressant

Guaifenesin 400 mg • Expectorant

MULTI-SYMPTOM

Relief of:

  • Headache, Fever, Sore Throat & Aches & Pains
  • Nasal/Sinus Congestion, Sinus Pressure
  • Cough, Chest Congestion
  • Thins & Loosens Mucus

For Ages 12+

9 fl oz (266 mL)

3001000211-47005

NDC 61941-0300-1


Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 20 mL) Purpose
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Phenylephrine HCl 10 mg Nasal decongestant
Directions
  • do not take more than directed

    (see Overdose warning)
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • Adults and children 12 years and older: 20 mL orally every 4 hours, not to exceed 6 doses in 24 hours.
  • Children under 12 years of age: Do not use unless directed by 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.
  • for children under 12 years of age
  • 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.
Questions?

1-800-505- 2653

(M-F: 9AM-5PM EST)


You may also report side effects to this phone number

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 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily 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 right away (1-800-222-1222). 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 20 mL contains:

    sodium 12 mg
  • tamper evident: do not use if foil seal under bottle cap is open or missing
  • store between 15-30°C (59-86°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

When Using This Product (When using this product)
  • do not use more than directed
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 7 days
  • 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 persistent headache. 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, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin
Principal Display Panel 266 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label)

MAXIMUM STRENGTH

Cold-EEZE®

Daytime Cold & Flu

Acetaminophen 650 mg • Pain Reliever/Fever Reducer

Phenylephrine HCl 10 mg • Nasal Decongestant

Dextromethorphan HBr 20 mg • Cough Suppressant

Guaifenesin 400 mg • Expectorant

MULTI-SYMPTOM

Relief of:

  • Headache, Fever, Sore Throat & Aches & Pains
  • Nasal/Sinus Congestion, Sinus Pressure
  • Cough, Chest Congestion
  • Thins & Loosens Mucus

For Ages 12+

9 fl oz (266 mL)

3001000211-47005

NDC 61941-0300-1


Advanced Ingredient Data


Raw Label Data

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