Children's Non-drowsy

Children's Non-drowsy
SPL v1
SPL
SPL Set ID 86730925-e349-4e1e-9140-c73c1facda45
Route
ORAL
Published
Effective Date 2013-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Glycerin Sorbitol Phosphoric Acid Polyethylene Glycols Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sodium Phosphate, Monobasic, Dihydrate

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2010-02-27

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 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 Or Comments?

call 1-800-632-6900

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

Compare to the active ingredient in CHILDREN'S CLARITIN®

**See side panel.

NDC 30142-092-08

2 YEARS & Older

Non-drowsy*

Children's

ALLERGY RELIEF

Loratadine Oral Solution 5 mg/5 mL

Antihistamine

Dye-Free

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Sugar Free

Indoor & Outdoor Allergies

*When taken as directed.

See Drug Facts Panel.

Grape Flavor

4 FL OZ (120 mL)

Kroger®

FROM OUR FAMILY TO YOURS


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

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 (Other information)
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)
Inactive Ingredients (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 Or Comments? (Questions or comments?)

call 1-800-632-6900

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

Compare to the active ingredient in CHILDREN'S CLARITIN®

**See side panel.

NDC 30142-092-08

2 YEARS & Older

Non-drowsy*

Children's

ALLERGY RELIEF

Loratadine Oral Solution 5 mg/5 mL

Antihistamine

Dye-Free

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Sugar Free

Indoor & Outdoor Allergies

*When taken as directed.

See Drug Facts Panel.

Grape Flavor

4 FL OZ (120 mL)

Kroger®

FROM OUR FAMILY TO YOURS


Advanced Ingredient Data


Raw Label Data

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