Other
Drug Facts
Distributed by:
ProPhase Labs, Inc.
PO Box 1349
Doylestown, PA 18901
Cold-eeze
FDA Label NDC 61941-0400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prophase Labs, Inc. for the product Cold-eeze (NDC 61941-0400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, ask a doctor before use if the child has, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
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
| 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
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)
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