Loratadine by American Health Packaging LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

• 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.

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

Other Information

• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture
• FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

for 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

Principal Display Panel – Carton – 10 mg

NDC 68084- 248-01

NON-DROWSY* 24 Hour Allergy Relief
Loratadine Tablets, USP

Antihistamine Indoor & Outdoor Allergies

10 mg

100 Tablets (10 x 10)

* When taken as directed. See Drug Facts Panel.

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

801697
0224801/0119

Principal Display Panel – Blister – 10 mg

Allergy Relief
Loratadine
Tablet, USP 10 mg

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68084-248(NDC:51660-526)
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 (White to Off 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: 68084-248-01	100 in 1 BOX, UNIT-DOSE	11/09/2007
1	NDC: 68084-248-11	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
ANDA	ANDA076134	11/09/2007

Labeler - American Health Packaging (929561009)

Establishment
Name	Address	ID/FEI	Business Operations
American Health Packaging		929561009	repack(68084-248)