GOOD SENSE CHILDRENS LORATADINE- loratadine solution

Good Sense by

Drug Labeling and Warnings

Good Sense by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

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:

• runny nose
• itchy, watery eyes
• sneezing
• 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

• 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

• do not use if carton is opened, or if imprinted safety seal is broken or missing
• see bottom panel for expiration date
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed By
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC: 50804-092-08

GOODSENSE®

Ages two years & older

Children's
Loratadine
Syrup

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

24 Hour Non-Drowsy†
Allergy Relief Sugar Free
Indoor & Outdoor Allergy

Relief of:
Sneezing,
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Grape
flavored syrup
Dye free

Compare to active ingredient in
Children's Claritin®*

100%
SATISFACTION
GUARANTEED

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

INGREDIENTS AND APPEARANCE

GOOD SENSE   CHILDRENS LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-092
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
glycerin (UNII: PDC6A3C0OX)
sorbitol (UNII: 506T60A25R)
phosphoric acid (UNII: E4GA8884NN)
polyethylene glycols (UNII: 3WJQ0SDW1A)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium metabisulfite (UNII: 4VON5FNS3C)
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE (sugar free)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-092-08	1 in 1 CARTON
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076805	02/27/2010

Labeler - Geiss, Destin & Dunn, Inc. (076059836)