CLORRELIEF- chlorpheniramine maleate aerosol, spray

ClorRelief by

Drug Labeling and Warnings

ClorRelief by is a Otc medication manufactured, distributed, or labeled by FERRER MEDICAL INNOVATIONS LLC, Xlear Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorpheniramine Maleate 0.5%

Purpose

Antihistamine

Uses

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

• runny nose
• itchy nose or throat
• sneezing itchy, watery eyes

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

INGREDIENTS AND APPEARANCE

CLORRELIEF 
chlorpheniramine maleate aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82643-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	SPEARMINT, PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82643-002-15	1 in 1 CARTON	04/24/2023
1		15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/21/2023

Labeler - FERRER MEDICAL INNOVATIONS LLC (041608434)

Registrant - FERRER MEDICAL INNOVATIONS LLC (041608434)

Establishment
Name	Address	ID/FEI	Business Operations
Xlear Inc.		839884058	manufacture(82643-002)