COLD-EEZE  CHILDRENS NIGHTTIME COLD AND COUGH RELIEF- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid 
ProPhase Labs, Inc.

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.

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Cold-EEZE®
Children's Nighttime Cold & Cough Relief

Drug Facts

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

Warnings

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.

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.

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.

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

Other information

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

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

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
COLD-EEZE   CHILDRENS NIGHTTIME COLD AND COUGH RELIEF
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61941-0401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg  in 10 mL
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg  in 10 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Edetate Disodium (UNII: 7FLD91C86K)  
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
FD&C Red NO. 40 (UNII: WZB9127XOA)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Water (UNII: 059QF0KO0R)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
Sorbitol (UNII: 506T60A25R)  
Sucralose (UNII: 96K6UQ3ZD4)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61941-0401-1180 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2016
Labeler - ProPhase Labs, Inc. (620557298)
Establishment
NameAddressID/FEIBusiness Operations
ProPhase Labs, Inc.620557298LABEL(61941-0401) , ANALYSIS(61941-0401) , REPACK(61941-0401)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaloz Manufacturing, Inc.067101998MANUFACTURE(61941-0401) , PACK(61941-0401) , REPACK(61941-0401)

Revised: 1/2016
Document Id: a56a8bf2-0414-4a19-8321-eba58c3d5ed5
Set id: 74cef3aa-282f-4244-9541-c35e2109c85a
Version: 1
Effective Time: 20160129
 
ProPhase Labs, Inc.