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

Cold-EEZE by

Drug Labeling and Warnings

Cold-EEZE by is a Otc medication manufactured, distributed, or labeled by ProPhase Labs, Inc., Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL)	Purpose
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

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

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

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

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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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61941-0400
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	20 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (Clear/White)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61941-0400-1	180 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/01/2016

Labeler - ProPhase Labs, Inc. (620557298)

Establishment
Name	Address	ID/FEI	Business Operations
ProPhase Labs, Inc.		620557298	LABEL(61941-0400) , ANALYSIS(61941-0400) , REPACK(61941-0400)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	MANUFACTURE(61941-0400) , PACK(61941-0400) , REPACK(61941-0400)