OTC Medication Information: Loratadine

LORATADINE- loratadine tablet
Apotex Corp.

10mg-100btl

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 induction seal, with “Lift N Peel” tab, under cap is broken or missing
  • store between 2°C and 30°C (36°F and 86°F)
  • protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call 1-800-706-5575 , weekdays, 8:30 am — 5:00 pm Eastern Standard Time

Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326

Revised: August 2018

PRINCIPAL DISPLAY PANEL — 10 mg

APOTEX CORP. NDC 60505-0147-1

Loratadine Tablets 10 mg

Non-Drowsy*

Antihistamine/ Original Prescription Strength

Compare to the active ingredient in Claritin® Tablets

Indoor & Outdoor Allergies

24 hour

Relief of

LORATADINE
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-0147
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code LOR;10;APO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0147-1 100 TABLET in 1 BOTTLE None
2 NDC:60505-0147-8 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076471 01/24/2005
Labeler — Apotex Corp. (845263701)

Revised: 11/2023 Apotex Corp.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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