SPL v2
SPL
SPL Set ID a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5
Route
ORAL
Published
Effective Date 2020-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Aspartame Silicon Dioxide Crospovidone Magnesium Stearate Starch, Corn Mannitol Microcrystalline Cellulose Sodium Stearyl Fumarate

Identifiers & Packaging

Pill Appearance
Imprint: UpArrowhead43 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-09-10

Description

Drug Facts Active ingredient (in each tablet)                                                                  Purpose Loratadine USP, 10 mg………………………………….....................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 a 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor Other information Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet. safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister FDA approved acceptance criteria for assay and organic impurities differs from USP test Inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate Questions or comments? Advagen - 866-488-0312 Distributed by: Advagen Pharma Ltd East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd., Thane 421506, India. Rev. 02, 11/24


Medication Information

Description

Drug Facts Active ingredient (in each tablet)                                                                  Purpose Loratadine USP, 10 mg………………………………….....................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 a 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. Directions place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor Other information Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet. safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister FDA approved acceptance criteria for assay and organic impurities differs from USP test Inactive ingredients aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate Questions or comments? Advagen - 866-488-0312 Distributed by: Advagen Pharma Ltd East Windsor, NJ 08520, USA Manufactured by: Rubicon Research Ltd., Thane 421506, India. Rev. 02, 11/24

Section 42229-5

Note:Imprint Code - Λ indicated as UpArrowhead in Drug Listing Data Element (DLDE) section.

Section 55106-9
Drug Facts
Active ingredient (in each tablet)                                                                  Purpose
Loratadine USP, 10 mg………………………………….....................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 useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using a productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor ifan 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.
Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age ask a doctor
Consumers with liver or kidney disease ask a doctor
Other information
  • Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet.
  • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • FDA approved acceptance criteria for assay and organic impurities differs from USP test
Inactive ingredients
aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate
Questions or comments?

Advagen - 866-488-0312
Distributed by:

Advagen Pharma Ltd


East Windsor, NJ 08520, USA


Manufactured by:

Rubicon Research Ltd.,


Thane 421506, India.

Rev. 02, 11/24

Principal Display Panel

Loratadine Orally Disintegrating Tablets USP 10 mg - 10 Tablets - NDC 72888-029-09

Loratadine Orally Disintegrating Tablets USP 10 mg - 30 Tablets - NDC 72888-029-11


Structured Label Content

Section 42229-5 (42229-5)

Note:Imprint Code - Λ indicated as UpArrowhead in Drug Listing Data Element (DLDE) section.

Section 55106-9 (55106-9)
Drug Facts
Active ingredient (in each tablet)                                                                  Purpose
Loratadine USP, 10 mg………………………………….....................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 useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using a productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor ifan 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.
Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age ask a doctor
Consumers with liver or kidney disease ask a doctor
Other information
  • Phenylketonurics: contains phenylalanine (a component of aspartame) 1.52 mg per 10 mg orally disintegrating tablet.
  • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally Disintegrating Tablets USP 10 mg is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • FDA approved acceptance criteria for assay and organic impurities differs from USP test
Inactive ingredients
aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate
Questions or comments?

Advagen - 866-488-0312
Distributed by:

Advagen Pharma Ltd


East Windsor, NJ 08520, USA


Manufactured by:

Rubicon Research Ltd.,


Thane 421506, India.

Rev. 02, 11/24

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Loratadine Orally Disintegrating Tablets USP 10 mg - 10 Tablets - NDC 72888-029-09

Loratadine Orally Disintegrating Tablets USP 10 mg - 30 Tablets - NDC 72888-029-11


Advanced Ingredient Data


Raw Label Data

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