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NDC 30142-0984-30 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 KROGER COMPANY. 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: 30142-0984-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	30142-0984
Product ID	30142-984_5e38fb1a-88f5-408d-b3c1-4a1e93d41283
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, CHEWABLE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	KROGER COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA210088
Listing Certified Through	2024-12-31

Package

Package Images

NDC 30142-0984-30 (30142098430)

Pricing Information	N/A
NDC Package Code	30142-984-30
Billing NDC	30142098430
Package	3 BLISTER PACK in 1 CARTON (30142-984-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Start Date	2021-04-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f5fbfb52-197c-437c-8977-23bd7f2ac7bd 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
▪: 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 beast-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 (1800-222-1222).

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° to 77°F).

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

1800-632-6900

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-984
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PURPLE (light purple to dark purple)	Score	no score
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	106
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30142-984-30	3 in 1 CARTON	04/02/2021
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	04/02/2021

Labeler - KROGER COMPANY (006999528)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		184769029	MANUFACTURE(30142-984)

Revised: 4/2021

Document Id: 5e38fb1a-88f5-408d-b3c1-4a1e93d41283

Set id: f5fbfb52-197c-437c-8977-23bd7f2ac7bd

Version: 2

Effective Time: 20210408