Loratadine tablet

Drug facts

Active ingredient (in each tablet)

Loratadine USP 10 mg

Purpose

Antihistamine

Uses

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


  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

Do not use

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

Ask a doctor before use if you have

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

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 (1-800-222-1222) right away.

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


  • Tamper-evident: do not use if foil seal under cap, printed with SEALED for YOUR PROTECTION is missing, open or broken
  • store at 20 to 25C (68 to 77F)
  • protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?


call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
Made in India
Code: TS/DRUGS/22/2009

Ingredients and appearance - Product information

Loratadine tablet- Loratadine

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-831
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Starch, corn ( UNII: O8232NY3SJ)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)

Product Characteristics

Color WHITE (White to Off-white) Shape ROUND
Size 6 mm Score 1
Imprint Code 39;L

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA208314 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 ANALYSIS( 58602-831), MANUFACTURE( 58602-831)

Package label-principal display panel - 10 mg (45 tablets bottle)

NDC 58602-831-17
PH primary Health
Non-Drowsy *
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

24 Hour

*When taken
as directed
See Drug
Facts Panel. 45 Tablets

Package label-principal display panel - 10 mg container carton (45 tablets)

NDC 58602-831-17
PH primary Health
Non-Drowsy *
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

24 Hour

*When taken
as directed
See Drug
Facts Panel. 45 Tablets

Package label.principal display panel