Loratadine Allergy Relief

Loratadine Allergy Relief
SPL v5
SPL
SPL Set ID 40914eeb-3a85-4691-9fb8-2df72ba1f709
Route
ORAL
Published
Effective Date 2011-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2017-11-01
Description

Drug Facts

Purpose

Antihistamine

How Supplied

NDC: 71335-0100-1: 20 Tablets in a BOTTLE NDC: 71335-0100-2: 30 Tablets in a BOTTLE NDC: 71335-0100-3: 60 Tablets in a BOTTLE NDC: 71335-0100-4: 14 Tablets in a BOTTLE NDC: 71335-0100-5: 10 Tablets in a BOTTLE NDC: 71335-0100-6: 90 Tablets in a BOTTLE NDC: 71335-0100-7: 28 Tablets in a BOTTLE NDC: 71335-0100-8: 15 Tablets in a BOTTLE NDC: 71335-0100-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

NDC: 71335-0100-1: 20 Tablets in a BOTTLE

NDC: 71335-0100-2: 30 Tablets in a BOTTLE

NDC: 71335-0100-3: 60 Tablets in a BOTTLE

NDC: 71335-0100-4: 14 Tablets in a BOTTLE

NDC: 71335-0100-5: 10 Tablets in a BOTTLE

NDC: 71335-0100-6: 90 Tablets in a BOTTLE

NDC: 71335-0100-7: 28 Tablets in a BOTTLE

NDC: 71335-0100-8: 15 Tablets in a BOTTLE

NDC: 71335-0100-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Drug Facts

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

Drug Facts

Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51945-4

Loratadine 10mg Tablet

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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
Questions?

call 1-800-406-7984

Other Information
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

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)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Section 51945-4 (51945-4)

Loratadine 10mg Tablet

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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
Questions?

call 1-800-406-7984

How Supplied (HOW SUPPLIED)

NDC: 71335-0100-1: 20 Tablets in a BOTTLE

NDC: 71335-0100-2: 30 Tablets in a BOTTLE

NDC: 71335-0100-3: 60 Tablets in a BOTTLE

NDC: 71335-0100-4: 14 Tablets in a BOTTLE

NDC: 71335-0100-5: 10 Tablets in a BOTTLE

NDC: 71335-0100-6: 90 Tablets in a BOTTLE

NDC: 71335-0100-7: 28 Tablets in a BOTTLE

NDC: 71335-0100-8: 15 Tablets in a BOTTLE

NDC: 71335-0100-9: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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

Loratadine, USP 10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:06.241497 · Updated: 2026-03-14T23:02:58.626725