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  5. Label Information: Cold-eeze Childrens Daytime Cough And Chest Congestion Relief

FDA Label for Cold-eeze Childrens Daytime Cough And Chest Congestion Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. OTC - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL - 180 ML BOTTLE LABEL

Cold-eeze Childrens Daytime Cough And Chest Congestion Relief Product Label

The following document was submitted to the FDA by the labeler of this product Prophase Labs, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901


Otc - Purpose



Active Ingredients (in each 5 mL)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Guaifenesin 100 mgExpectorant

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

Otc - Do Not Use



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.


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

Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



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).


Directions



  • measure with dosing cup provided
  • dose as follows or as directed by a doctor
  • mL = milliliter
    • AgeDose
    children 6 years to under 12 years5 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 years2.5 mL (1/2 tsp) - 5 mL (1 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
    children under 4 yearsdo not use

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


Questions?



1-800-505-2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number


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:

* Please review the disclaimer below.