Search by Drug Name or NDC

NDC 00378-8880-10 Loratadine 10 mg/1 Details

Loratadine 10 mg/1

Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 00378-8880-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	00378-8880
Product ID	0378-8880_1392dd15-842c-4689-87ba-caafc0503bca
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Loratadine
Proprietary Name Suffix	n/a
Non-Proprietary Name	loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Mylan Pharmaceuticals Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076154
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00378-8880-10 (00378888010)

Pricing Information	N/A
NDC Package Code	0378-8880-10
Billing NDC	00378888010
Package	1000 TABLET in 1 BOTTLE, PLASTIC (0378-8880-10)
Marketing Start Date	2011-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3b307aea-5a68-4c82-959a-cda4ffbd0a4a Details

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:

•: 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.

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 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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0378-8880
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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	G;L;10
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0378-8880-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076154	06/01/2011

Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2013

Document Id: 1392dd15-842c-4689-87ba-caafc0503bca

Set id: 3b307aea-5a68-4c82-959a-cda4ffbd0a4a

Version: 6

Effective Time: 20131115