f12eb5ec-2eb4-4990-9f43-73469c2744d3 — v1

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Version

v1

Effective date

July 30, 2009

Original packager

Sections captured

17

Identifiers

Document ID
12ba6dc3-25db-4c80-aff5-f67c0f72f5f5
Set ID
f12eb5ec-2eb4-4990-9f43-73469c2744d3
Application numbers
Product NDCs
Package NDCs
Original packager NDCs

Names & Manufacturers

Brand names
Generic names
Manufacturer names
Product types

Substances & Pharmacology

Substance names
Routes
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient (in each 5 mL) Loratadine 5 mg
Ask Doctor (1)

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Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Do Not Use (1)

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Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Dosage And Administration (1)

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Directions adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor
Dosage And Administration Table (1)

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

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Inactive ingredients artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
Indications And Usage (1)

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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
Keep Out Of Reach Of Children (1)

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Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (2)

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PRINCIPAL DISPLAY PANEL - 4 FL OZ Label Original Prescription Strength RITE AID PHARMACY Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5mL Antihistamine 4 FL OZ (120 mL) Principle Display Panel - 4 FL OZ Label

Sequence 2

PRINCIPAL DISPLAY PANEL - 4 FL OZ carton RITE AID PHARMACY Compare to active ingredient in Children's Claritin ® † Original Prescription Strength Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5mL Antihistamine Grape Flavored Syrup Ages 2 years and older 24-Hour Allergy Relief Non-Drowsy* Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 4 FL OZ (120 mL) *When Taken As Directed. See Drug Facts Panel Principle Display Panel - 4 FL OZ carton
Pregnancy Or Breast Feeding (1)

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If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

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Purpose Antihistamine
Spl Product Data Elements (1)

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Loratadine Loratadine Loratadine Loratadine citric acid monohydrate glycerin propylene glycol water sodium benzoate sodium metabisulfite sucrose Clear, colorless to light yellow
Spl Unclassified Section (2)

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Drug Facts

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DISTRIBUTED BY RITE AID CORPORATION HARRISBURG, PA 17105 Made in Israel. 72700-0509-0 575
Stop Use (1)

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Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Storage And Handling (1)

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Other information safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)
Warnings (1)

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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. side effects occur. You may report side effects to FDA at 1-800-FDA-1088. 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.
When Using (1)

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