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Loratadine by Contract Pharmacy Services-PA

Medically reviewed on September 19, 2017

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Contract Pharmacy Services-PA
NDC Code: 67046-453

Drug Facts 453

Active Ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

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

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 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
  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • Safety sealed: do not use if open or torn (for blister package only).

  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

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

Questions or comments?

1-800-525-8747

10-2015M

Sandoz Inc.

Princeton, NJ 08540

10 mg Label

NDC 67046-453-30 Non-Drowsy*

Loratadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-453(NDC:0781-5077)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeGG296
Contains    
Packaging
#Item CodePackage Description
1NDC:67046-453-077 TABLET in 1 BLISTER PACK
2NDC:67046-453-1414 TABLET in 1 BLISTER PACK
3NDC:67046-453-1515 TABLET in 1 BLISTER PACK
4NDC:67046-453-2121 TABLET in 1 BLISTER PACK
5NDC:67046-453-2828 TABLET in 1 BLISTER PACK
6NDC:67046-453-3030 TABLET in 1 BLISTER PACK
7NDC:67046-453-6060 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520909/19/2017
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIOperations
Coupler Enterprises945429777repack(67046-453)

 
Contract Pharmacy Services-PA

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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