CHILDRENS ALLERGY DYE FREE- loratadine liquid

Childrens Allergy by

Drug Labeling and Warnings

Childrens Allergy by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• sneezing
• runny nose
• itchy, watery eyes
• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product,

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

 an allergic reaction to this product occurs. Seek medical help right away

If pregnant or breast-feeding,

 ask a health professional before use.

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

• use only with enclosed dosing cup

• age: dose
• adults and children 6 years and over: 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
• children 2 to under 6 years of age: 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
• children under 2 years of age: ask a doctor
• consumers with liver or kidney disease: ask a doctor

Other information

• each teaspoonful contains: sodium 1 mg
• store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose

Questions or comments?

 call 1-248-449-9300- Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the active ingredient in Children's Claritin® Allergy

Non-Drowsy*

Children's Allergy

Indoor & Outdoor Allergies

Loratadine Oral Solution 5mg/5mL Anthistamine

24 Hour Relief of:

Running Nose

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

ages 2 years & Older

Alcohol-Free

Sugar-Free

Dye-Free Grape flavor

*When taken as directed See Drug Facts panel.

FL OZ (mL)

**This product is not manufactured or distributed by MSD Consumer Care, Inc, distributor of Children's Claritin® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFTEY SEAL AROUND BOTTLE IS BROKEN OR MISSING.

Distributed by C.D.M.A.,Inc.©

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

Quality Choice Non-Drowsy Children's Allergy

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY  DYE FREE
loratadine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-096
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-096-04	1 in 1 BOX	01/31/2015	12/31/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077421	01/31/2015	12/31/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)