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allergy relief

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

loratadine 10mg

Purpose

antihistamine

allergy relief 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

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

Ask Doctor

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

When Using

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

Stop Use

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

Pregnancy 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.

Overdose

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

Other Information

  • safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only)
  • safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only)
  • store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

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

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions

call 1-800-452-0051

 

 Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

copyright 2009 CVS/pharmacy.

www.cvs.com

1-800-SHOP-CVS

Principal Display

allergy relief
CVS

allergy relief

loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6066
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
lactose monohydrate
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm GG;296 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 5 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 10 in 1 BLISTER PACK
5 120 in 1 BOTTLE
6 365 in 1 BOTTLE
7 NDC:0067-6066-85 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA075209 2010-01-04


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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