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NDC 51660-0753-31 Loratadine 5 mg/1 Details

Loratadine 5 mg/1

Loratadine is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories 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: 51660-0753-31
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	51660-0753
Product ID	51660-753_48a60b3d-d011-4d0f-84dc-414c713c76ba
Associated GPIs
GCN Sequence Number	062340
GCN Sequence Number Description	loratadine TAB CHEW 5 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	98118
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	Loratadine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Ohm Laboratories Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210088
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0753-31 (51660075331)

Pricing Information
NDC Package Code	51660-753-31
Billing NDC	51660075331
Package	3 BLISTER PACK in 1 CARTON (51660-753-31) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2018-06-01
NDC Exclude Flag	N
Price Per Unit	0.404
Pricing Unit	EA
Effective Date	2022-05-18
NDC Description	CHILD LORATADINE 5 MG TAB CHEW
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b83de07d-37f4-42b4-b43e-29173454bef0 Details

Active ingredient (in each tablet)

Loratadine USP, 5 mg

Purpose

Antihistamine

Uses

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

•: runny nose
•: sneezing
•: 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 doctorbefore 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.

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

•: chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

•: Phenylketonurics: contains phenylalanine 1.25 mg per tablet.
•: TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
•: store between 20° to 25°C (68° and 77°F).

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0619

Principal Display Panel – 30 Chewable Tablet Blister Pack Carton

NDC 51660-753-31

†Compare to the active ingredient of Children’s Claritin® Chewable

ages 2 years and older

Children’s

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Grape Flavored

Non-Drowsy*

24 Hour Relief Of:

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

*When taken as directed. See Drug Facts Panel.

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-753
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	PURPLE (light purple to dark purple)	Score	no score
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	753
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-753-31	3 in 1 CARTON	06/01/2018
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	ANDA210088	06/01/2018

Labeler - Ohm Laboratories Inc. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(51660-753)

Revised: 7/2019

Document Id: 48a60b3d-d011-4d0f-84dc-414c713c76ba

Set id: b83de07d-37f4-42b4-b43e-29173454bef0

Version: 4

Effective Time: 20190717