Label: COLD-EEZE CHILDRENS DAYTIME COUGH AND CHEST CONGESTION RELIEF- dextromethorphan hydrobromide and guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 29, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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
  • Warnings

    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

    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.

    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

  • SPL UNCLASSIFIED SECTION

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

  • 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

    PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    COLD-EEZE   CHILDRENS DAYTIME COUGH AND CHEST CONGESTION RELIEF
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Propyl Gallate (UNII: 8D4SNN7V92)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Sorbitol (UNII: 506T60A25R)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITE (Clear/White) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61941-0400-1180 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34101/01/2016
    Labeler - ProPhase Labs, Inc. (620557298)
    Establishment
    NameAddressID/FEIBusiness Operations
    ProPhase Labs, Inc.620557298LABEL(61941-0400) , ANALYSIS(61941-0400) , REPACK(61941-0400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998MANUFACTURE(61941-0400) , PACK(61941-0400) , REPACK(61941-0400)
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