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Loratadine by REMEDYREPACK INC.

Medically reviewed on May 1, 2018

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0325

Drug Facts

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

DRUG: Loratadine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0325-0

NDC: 70518-0325-1

NDC: 70518-0325-2

NDC: 70518-0325-3

NDC: 70518-0325-4

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: GG296

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 7 in BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • CELLULOSE, MICROCRYSTALLINE
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0325(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:70518-0325-020 TABLET in 1 BOTTLE, PLASTIC
2NDC:70518-0325-17 TABLET in 1 BLISTER PACK
3NDC:70518-0325-230 TABLET in 1 BLISTER PACK
4NDC:70518-0325-3100 TABLET in 1 BOTTLE, PLASTIC
5NDC:70518-0325-430 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520903/16/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

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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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