CLORRELIEF KIDS- chlorpheniramine maleate aerosol, spray 
FERRER MEDICAL INNOVATIONS LLC

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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ClorRelief KIDs (Chlorpheniramine Maleate 0.5%) Antihistamine Oral Spray

Active ingredient

Chlorpheniramine Maleate 0.5%

Purpose

Antihistamine

Uses

Temporarily relieves symptoms of hay fever or other upper respiratory allergies:

Warnings

Ask a doctor before use if you have

glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

you are taking sedatives or tranquilizers

When using this product

  • you may get drowsy
  • avoid alcoholic drinks, sedatives & tranquilizers, may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breastfeeding,

ask your doctor before use.

Keep out of reach of children

Do not use to make a child sleepy. In case of overdose, getmedical help or contact a Poison Control Center right away.

Inactive ingredients

Aloe Vera, glycerin, grapefruit seed extract, hyaluronic acid, peppermint flavor, purified water, stevia, xylitol.

Directions

Adults and children 12 years and over:

For each application, spray 4 times every 4 to 6 hours,

do not exceed 6 applications in 24 hours.

Children 6 to under 12 years of age:
Should be supervised in the use of this product. For each application, spray 2 times every 4 to 6 hours. Do not exceed 3 applications in 24 hours.

Children 4 to under 6 years of age:
Do not use unless directed by a doctor.

Children under 4 years of age:
Do not use.

Other Information

Store at room temperature 15-30° C (59-86° F)

ClorRelief Box

ClorRelief Kids Carton Outline

CLORRELIEF KIDS 
chlorpheniramine maleate aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82643-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
PEPPERMINT (UNII: V95R5KMY2B)  
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
HYALURONIC ACID (UNII: S270N0TRQY)  
STEVIA LEAF (UNII: 6TC6NN0876)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82643-011-151 in 1 CARTON04/24/2023
115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/21/2023
Labeler - FERRER MEDICAL INNOVATIONS LLC (041608434)
Registrant - FERRER MEDICAL INNOVATIONS LLC (041608434)
Establishment
NameAddressID/FEIBusiness Operations
Xlear Inc.839884058manufacture(82643-011)

Revised: 4/2023
Document Id: fa1c1c15-c9a3-9d7f-e053-6294a90a9e32
Set id: fa1c1bde-d620-6163-e053-6394a90a3c2f
Version: 1
Effective Time: 20230424
 
FERRER MEDICAL INNOVATIONS LLC