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Loratadine Tablet: Package Insert / Prescribing Info

Package insert / product label
Dosage form: tablet
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Active ingredient

(in each tablet)

Loratadine USP, 10 mg

Purpose

Antihistamine

Indications and Usage for Loratadine Tablet

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.

Loratadine Tablet Dosage and Administration

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 of kidney disease

ask a doctor

Other information

Tamper Evident: do not use if foil seal under cap is missing, open or broken.
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India
Code No.: MH/DRUGS/25/NKD/89

PRODUCT PACKAGING

NDC 0378-8880-10

Original Prescription Strength

Non-Drowsy*

Loratadine
Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

RMX8880C1

100 Tablets

Loratadine Tablets 10 mg Bottles Front First Layer
Loratadine Tablets 10 mg Bottles Back of Front Layer
Loratadine Tablets 10 mg Bottles Base Layer
LORATADINE
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0378-8880
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeG;L;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-8880-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07615406/01/2011
Labeler - Mylan Pharmaceuticals Inc. (059295980)

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