Label: COLD-EEZE CHILDRENS DAYTIME COUGH AND CHEST CONGESTION RELIEF- dextromethorphan hydrobromide and guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 61941-0400-1 - Packager: ProPhase Labs, Inc.
- 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
- ACTIVE INGREDIENT
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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
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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
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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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
Children's
Cold-EEZE®
Daytime
Cough & Chest
Congestion ReliefGuaifenesin 100 mg • Expectorant
Dextromethorphan HBr 5 mg • Cough Suppressant
MULTI-SYMPTOM
Relief of:
- ✓
- Cough
- ✓
- Breaks Up Mucus
- ✓
- Chest Congestion
Alcohol Free
Dye FreeCherry Flavor
For Ages 4+
6 fl oz (180 mL)3001000215--47009
NDC 61941-0400-1
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INGREDIENTS AND APPEARANCE
COLD-EEZE CHILDRENS DAYTIME COUGH AND CHEST CONGESTION RELIEF
dextromethorphan hydrobromide and guaifenesin liquidProduct 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)