Loratadine ODT description, usages, side effects, indications, overdosage, supplying and lots more!

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Loratadine ODT

SAFEWAY INC.
Ranbaxy Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 (1-800-222-1222).

DIRECTIONS

  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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

  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS OR COMMENTS?

Call 1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL

NDC 21130-527-69

Compare to Claritin ® RediTabs ® active ingredient

Original Prescription Strength

Non-Drowsy *

24-Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

  • No Water Needed
  • Melts in Your Mouth

Relief of:

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

For Adults and Children Six Years and Older

* When taken as directed.

See Drug Facts Panel.

10 ORALLY DISINTEGRATING TABLETS

SAFEWAY

DISTRIBUTED BY SAFEWAY INC.

5082800/R0212

Loratadine ODT

Loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-527
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
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
mannitol
SODIUM STEARYL FUMARATE

Product Characteristics

Color Size Imprint Code Shape
white (White to Off-White) 10 mm RC17 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-527-69 10 in 1 BLISTER PACK
2 NDC:21130-527-31 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077153 2007-08-31


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Be sure to consult your doctor before taking any medication!
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