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NDC 63187-0100-20 Loratadine Allergy Relief 10 mg/1 Details

Loratadine Allergy Relief 10 mg/1

Loratadine Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0100-20
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	63187-0100
Product ID	63187-100_171ce022-2573-4dc9-b5fd-359a4d16d94d
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 Allergy Relief
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	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076134
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0100-20 (63187010020)

Pricing Information	N/A
NDC Package Code	63187-100-20
Billing NDC	63187010020
Package	20 TABLET in 1 BOTTLE (63187-100-20)
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb Details

ACTIVE INGREDIENT(S)

Loratadine USP, 10 mg

PURPOSE

Antihistamine

USE(S)

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 and kidney disease	ask a doctor

OTHER INFORMATION

•: store between 20 and 25° C (68 and 77° F)
•: protect from excessive moisture
•: TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

NDC 63187-100-10

†Compare to the active ingredient of Claritin®

NON-DROWSY*

24 HourAllergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

•: Sneezing
•: Runny Nose
•: Itchy, Watery Eyes
•: Itchy Throat or Nose

10 Tablets

When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5069178/0908

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

LORATADINE ALLERGY RELIEF

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-100(NDC:51660-526)
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	RX526
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-100-10	10 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
2	NDC:63187-100-20	20 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019
3	NDC:63187-100-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076134	08/28/2003

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-100) , RELABEL(63187-100)

Revised: 11/2022

Document Id: 171ce022-2573-4dc9-b5fd-359a4d16d94d

Set id: a6b9a1bf-1013-4a15-b3b2-a226a75a1ffb

Version: 5

Effective Time: 20221101