Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 4fa705fb-859e-4046-b153-a8338c50a97d
Route
ORAL
Published
Effective Date 2020-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Caprylic/capric Acid Fd&c Blue No. 1 Gelatin Glycerin Hypromelloses Hydrolysed Bovine Collagen (enzymatic; 2000-5000 Mw) Isopropyl Alcohol Mannitol Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L10 Shape: oval Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Completed Since 2020-03-20 Until 2024-12-23
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
Section 42229-5

†This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

Blister carton contain the following:

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Do not use if carton is open, or if individual blister unit is open or torn

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Directions

adults and children 6 years and over

1 capsule daily; not more than 1 capsule in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Do Not Use

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

Other Information
  • Tamper-evident: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Principal Display Panel

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 Capsule)

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
Section 42229-5 (42229-5)

†This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS®.

Blister carton contain the following:

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Do not use if carton is open, or if individual blister unit is open or torn

Manufactured for:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

Purpose

Antihistamine

Directions

adults and children 6 years and over

1 capsule daily; not more than 1 capsule in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

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: do not use if foil seal under cap, printed with “Sealed for your protection” is missing, open or broken. (For Bottle Labels and Cartons)
  • Safety sealed: do not use if individual blister unit printed with Loratadine Capsule, 10 mg is open or torn. (For Blister Carton)
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing
Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, gelatin, glycerin, hypromellose, hydrolyzed collagen, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

Principal Display Panel

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 Capsule) (Active ingredient (in each capsule))

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:02.222453 · Updated: 2026-03-14T23:06:18.731306