Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 603b96bf-ab3f-4ac2-966b-8060f1cfe745
Route
ORAL
Published
Effective Date 2010-08-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: RX526 Shape: round Color: white Size: 7 mm Score: 1
Marketing Status
ANDA Active Since 2008-12-01

Description

Loratadine 10mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10mg

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
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.

Active Ingredient

Loratadine 10mg

Other Information
  • Safety sealed: do not use if the imprinted bottle seal is open or torn
  • Store at 15° - 30° C (59° - 86° F).
Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If
  • side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

IMDS INC.

Loratadine

(Compare to Claritin®)

30 TABLETS

10 mg

Relief of: Sneezing, Runny Nose,

Itchy Watery Eyes, Itchy Throat or Nose


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
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.

Active Ingredient (Active ingredient)

Loratadine 10mg

Other Information (Other information)
  • Safety sealed: do not use if the imprinted bottle seal is open or torn
  • Store at 15° - 30° C (59° - 86° F).
Inactive Ingredients (Inactive ingredients)

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

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.

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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

IMDS INC.

Loratadine

(Compare to Claritin®)

30 TABLETS

10 mg

Relief of: Sneezing, Runny Nose,

Itchy Watery Eyes, Itchy Throat or Nose


Advanced Ingredient Data


Raw Label Data

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