FDA Label for Loratadine

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PRINCIPAL DISPLAY PANEL – CARTON – 10 MG
PRINCIPAL DISPLAY PANEL – BLISTER – 10 MG

Loratadine Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

10 mg

Antihistamine
Indoor & Outdoor Allergies

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.