Cold-eeze®

Cold-eeze®
SPL v1
SPL
SPL Set ID ad03d349-c07c-41a2-9627-881098b3e85b
Route
ORAL
Published
Effective Date 2016-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Glycerin Propylene Glycol Water Propyl Gallate Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

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

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Section 50570-1

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Avoid foods or beverages that contain caffeine.

Section 55105-1
Active Ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • measure with dosing cup provided
  • dose as follows or as directed by a doctor
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL (1 tsp) - 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
children 4 years to under 6 years 2.5 mL (1/2 tsp) - 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
children under 4 years do not use
Questions?

1-800-505-2653

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


You may also report side effects to this phone number

Other Information
  • each 5 mL teaspoonful contains: sodium 3 mg
  • tamper evident: do not use if foil seal under bottle cap is open or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

citric acid anhydrous, flavors, disodium edetate, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Ask A Doctor Before Use If the Child Has
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 180 Ml Bottle Label

Children's

Cold-EEZE®

Daytime

Cough & Chest

Congestion Relief

Guaifenesin 100 mg • Expectorant

Dextromethorphan HBr 5 mg • Cough Suppressant

MULTI-SYMPTOM

Relief of:

  • Cough
  • Breaks Up Mucus
  • Chest Congestion

Alcohol Free

Dye Free

Cherry Flavor

For Ages 4+

6 fl oz (180 mL)

3001000215--47009

NDC 61941-0400-1


Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help your child get to sleep
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Section 50570-1 (50570-1)

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Avoid foods or beverages that contain caffeine.

Section 55105-1 (55105-1)
Active Ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 5 mg Cough suppressant
Guaifenesin 100 mg Expectorant
Directions
  • measure with dosing cup provided
  • dose as follows or as directed by a doctor
  • mL = milliliter
Age Dose
children 6 years to under 12 years 5 mL (1 tsp) - 10 mL (2 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
children 4 years to under 6 years 2.5 mL (1/2 tsp) - 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
children under 4 years do not use
Questions?

1-800-505-2653

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


You may also report side effects to this phone number

Other Information (Other information)
  • each 5 mL teaspoonful contains: sodium 3 mg
  • tamper evident: do not use if foil seal under bottle cap is open or missing
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, flavors, disodium edetate, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Principal Display Panel 180 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label)

Children's

Cold-EEZE®

Daytime

Cough & Chest

Congestion Relief

Guaifenesin 100 mg • Expectorant

Dextromethorphan HBr 5 mg • Cough Suppressant

MULTI-SYMPTOM

Relief of:

  • Cough
  • Breaks Up Mucus
  • Chest Congestion

Alcohol Free

Dye Free

Cherry Flavor

For Ages 4+

6 fl oz (180 mL)

3001000215--47009

NDC 61941-0400-1


Advanced Ingredient Data


Raw Label Data

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