Handy Solutions 24 Hour Allergy

Handy Solutions 24 Hour Allergy
SPL v3
SPL
SPL Set ID 67263031-9095-48f2-8b34-e589b28a7416
Route
ORAL
Published
Effective Date 2016-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Magnesium Stearate Starch, Corn Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: RX;526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2016-09-22

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

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

Directions

Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours

Children under 12 years: do not give to children under 12 years of age

Consumer with liver or kidney disease: ask a doctor before using

Do Not Use

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

Other Information

• Tamper evident sealed packets

• Do not use any opened or torn packets

• Store between 68°F and 77°F (20° and 25°C)

• Protect from excessive moisture

Package Labeling:

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments?

call 1-800-525-5097

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.

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Ask A Doctor Before Use If You Have

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


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

Purpose

Antihistamine

Directions

Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours

Children under 12 years: do not give to children under 12 years of age

Consumer with liver or kidney disease: ask a doctor before using

Do Not Use (Do not use)

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

Other Information (Other information)

• Tamper evident sealed packets

• Do not use any opened or torn packets

• Store between 68°F and 77°F (20° and 25°C)

• Protect from excessive moisture

Package Labeling:

Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments? (Questions or comments?)

call 1-800-525-5097

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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


Advanced Ingredient Data


Raw Label Data

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