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NDC 63654-0309-10 Allergy 10 mg/1 Details

Allergy 10 mg/1

Allergy is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Selder, S.A. de C.V.. 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: 63654-0309-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	63654-0309
Product ID	63654-309_39201d37-e750-420b-8035-feb97bc77c21
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	Allergy
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	Selder, S.A. de C.V.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076471
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63654-0309-10 (63654030910)

Pricing Information	N/A
NDC Package Code	63654-309-10
Billing NDC	63654030910
Package	1 BLISTER PACK in 1 CARTON (63654-309-10) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2014-12-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251 Details

Active ingredient

Loratadine 10mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy, watery eyes

■ 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

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.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

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

■ do not use if blister packaging is torn or open

Inactive ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Principal Display Panel

XL-3 Allergy Relief

INGREDIENTS AND APPEARANCE

ALLERGY

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63654-309
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	LOR;10;APO
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63654-309-10	1 in 1 CARTON	12/16/2014
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076471	12/16/2014

Labeler - Selder, S.A. de C.V. (824413629)

Revised: 12/2016

Document Id: 39201d37-e750-420b-8035-feb97bc77c21

Set id: afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251

Version: 4

Effective Time: 20161222