Loratadine Tablets, Usp Antihistamine

Loratadine Tablets, Usp Antihistamine
SPL v8
SPL
SPL Set ID 411f3692-99ff-49d7-8594-e6f404f5861f
Route
ORAL
Published
Effective Date 2016-03-15
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 2007-11-21
Description

Loratadine USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • sneezing
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
Do Not Use

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

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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).

Active Ingredient (in Each Tablet)

Loratadine USP, 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Principal Display Panel – Carton – 10 Mg

NDC 68084- 248-01

NON-DROWSY* 24 Hour Allergy Relief

Loratadine Tablets, USP

Antihistamine Indoor & Outdoor Allergies

10 mg

100 Tablets (10 x 10)

* When taken as directed. See Drug Facts Panel.

The drug product contained in this package is from

NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

801697

0224801/0119

Principal Display Panel – Blister – 10 Mg

Allergy Relief

Loratadine

Tablet, USP   10 mg

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • sneezing
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
Do Not Use (Do not use)

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

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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).

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

Loratadine USP, 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.

Principal Display Panel – Carton – 10 Mg (Principal Display Panel – Carton – 10 mg)

NDC 68084- 248-01

NON-DROWSY* 24 Hour Allergy Relief

Loratadine Tablets, USP

Antihistamine Indoor & Outdoor Allergies

10 mg

100 Tablets (10 x 10)

* When taken as directed. See Drug Facts Panel.

The drug product contained in this package is from

NDC # 51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

801697

0224801/0119

Principal Display Panel – Blister – 10 Mg (Principal Display Panel – Blister – 10 mg)

Allergy Relief

Loratadine

Tablet, USP   10 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.766169 · Updated: 2026-03-14T23:05:18.894850