a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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 | |
|
|
| 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 | |
|
|
| 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 | |
|
|
| 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 | |
|
|
| 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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:05.954923 · Updated: 2026-03-14T23:12:14.139281