Loratadine by Cardinal Health LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Drug Facts

Loratadine Tablets USP, 10 mg

Purpose

Antihistamine

Uses

Non-Drowsy* 24 Hour

*When taken as directed. See Drug Facts Panel.

Indoor and Outdoor Allergies

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: · itching of the nose or throat · runny nose · itchy, watery eyes · sneezing

Warnings

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

This package is intended for institutional use only.

This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

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

• 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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Other Information

store between 20 and 25°C (68 and 77°F) · protect from excessive moisture.

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

Questions? for Ranbaxy/Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from NDC#51660-526, Ohm Laboratories Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

americanhealthpackaging.com

An AmerisourceBergen Company

AMERICAN HEALTH PACKAGING is a trademark owned by its respective owner.

Distributed by:

Cardinal Health

Dublin, OH 43017

L4955647-10818

L4955647-20818

Principal Display Panel

Non-Drowsy* 24 Hour

Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine

10 Tablets

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55154-4976(NDC:68084-248)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55154-4976-0	10 in 1 BAG	06/14/2013
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/14/2013

Labeler - Cardinal Health (603638201)