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
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
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
Drug Facts
| Active Ingredients (in each 5 mL) | Purpose |
|---|---|
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
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.
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).
| 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 |
citric acid anhydrous, flavors, disodium edetate, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
1-800-505-2653
(M-F: 9AM-5PM EST)
You may also report side effects to this phone number
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
Children's
Cold-EEZE®
Daytime
Cough & Chest
Congestion Relief
Guaifenesin 100 mg • Expectorant
Dextromethorphan HBr 5 mg • Cough Suppressant
MULTI-SYMPTOM
Relief of:
Alcohol Free
Dye Free
Cherry Flavor
For Ages 4+
6 fl oz (180 mL)
3001000215--47009
NDC 61941-0400-1
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61941-0400-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-db77-f424-e053-dadaa90a57ce | Cold-EEZE ® Children's Daytime Cough & Chest Congestion Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61941-0400-1 | Cold-EEZE Childrens Daytime Cough and Chest Congestion Relief | 180 mL in 1 BOTTLE, UNIT-DOSE | LIQUID | 180 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61941-0400 | COLD-EEZE CHILDRENS DAYTIME COUGH AND CHEST CONGESTION RELIEF (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [PROPHASE LABS, INC.] | 1 | Legacy NDC, 1 package rows | 20160205_ad03d349-c07c-41a2-9627-881098b3e85b.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61941-0400 | 61941-0400-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| Guaifenesin | 495W7451VQ | ACTIB |
| Anhydrous Citric Acid | XF417D3PSL | IACT |
| Edetate Disodium | 7FLD91C86K | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Propyl Gallate | 8D4SNN7V92 | IACT |
| Sodium Benzoate | OJ245FE5EU | IACT |
| Sodium Citrate, Unspecified Form | 1Q73Q2JULR | IACT |
| Sorbitol | 506T60A25R | IACT |
| Sucralose | 96K6UQ3ZD4 | IACT |
| Xanthan Gum | TTV12P4NEE | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9c89c223-889a-455b-8fd7-ad7f49553bc7 | ad03d349-c07c-41a2-9627-881098b3e85b | 2016-01-29 | Warnings | 9c89c223-889a-455b-8fd7-ad7f49553bc7 ad03d349-c07c-41a2-9627-881098b3e85b |
Adverse event summaries are temporarily unavailable. Other product information remains available.