Cold-eeze
FDA Label NDC 61941-0401

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 61941-0401). 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, liver warning, allergy alert, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Otc - Purpose

Active Ingredients (in each 10 mL)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Diphenhydramine HCl 12.5mgAntihistamine/cough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporary relief for these common cold and flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose
    • sneezing
    • cough
    • controls cough to help your child get to sleep
    • temporarily reduces fever

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Allergy Alert

Acetaminophen may cause severe skin reactions.
Symptoms may include:

  • skin reddening
  • blisters
  • rash

    • If a skin reaction occurs, stop use and seek medical help right away.

    Avoid foods or beverages that contain caffeine.

Do Not Use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • to make a child sleepy
  • with any other drug containing diphenhydramine, even one used on the skin
  • 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.

Ask A Doctor Before Use If Your Child Has

  • liver disease
  • heart disease
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If Your Child Is

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When Using This Product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days
  • fever gets worse, or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed (see Overdose warning)
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter
  • children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours; do not give more than 5 doses in any 24-hour period
  • children under 6 years of age: do not use

Other Information

  • each 10 mL contains: sodium 6 mg
  • store between 20-25°C (68-77°F)
  • dosing cup provided
  • do not refrigerate
  • dosing cup provided
  • tamper evident: do not use if foil seal under bottle cap is open or missing

Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, 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®
Nighttime
Cold & Cough

3001000213--47011

NDC 61941-0401-1

Acetaminophen 325 mg • Pain Reliever/Fever Reducer

Diphenhydramine HCl 12.5 mg • Antihistamine/Cough Suppressant

Phenylephrine HCl 5 mg • Nasal Decongestant

MULTI-SYMPTOM

Relief of:

  • ✓Cough
  • ✓Sore Throat
  • ✓Fever
  • ✓Stuffy Nose

    • Alcohol Free

    Berry Flavor

    For Ages 6+
    6 fl oz (180 mL)

    Principal Display Panel (180 mL Bottle Label)

    Principal Display Panel (180 mL Bottle Label)

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