perrigo loratadine tablets, 10 mg drug facts

perrigo loratadine tablets, 10 mg drug facts
SPL v5
SPL
SPL Set ID a2c92766-df4e-4414-9c42-e18bcf9db6b4
Route
oral
Published
Effective Date 2022-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
lactose monohydrate magnesium stearate povidone, unspecified

Identifiers & Packaging

Pill Appearance
Imprint: L612 Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
anda active Since 2008-10-15
Purpose

Antihistamine

Description

Loratadine 10 mg

Medication Information

Active Ingredient

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
Purpose

Antihistamine

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
  • do not use if printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Description

Loratadine 10 mg

Do Not Use

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

Questions Or Comments?

1-800-719-9260

Repackaging Information

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

10mg

NDC 43353-259-60, Bottles of 90 Tablets

NDC 43353-259-18, Bottles of 3000 Tablets

NDC 43353-259-09, Bottles of 9000 Tablets

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20240409AMH

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. (1-800-222-1222)

Principal Display Panel 10 Mg

NDC 43353-259 - Loratadine 10 mg Tablets

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

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Antihistamine

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 (Other information)
  • do not use if printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Do Not Use (Do not use)

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Repackaging Information

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

10mg

NDC 43353-259-60, Bottles of 90 Tablets

NDC 43353-259-18, Bottles of 3000 Tablets

NDC 43353-259-09, Bottles of 9000 Tablets

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20240409AMH

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. (1-800-222-1222)

Principal Display Panel 10 Mg (PRINCIPAL DISPLAY PANEL - 10 mg)

NDC 43353-259 - Loratadine 10 mg Tablets

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: 2026-02-15T12:02:56.945853 · Updated: 2026-03-14T23:02:46.668637