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NDC 68788-7653-05 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 Preferred 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: 68788-7653-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	68788-7653
Product ID	68788-7653_e13262ad-5756-4568-9752-1507260deea6
Associated GPIs	41550030000320
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	Preferred Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076301
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68788-7653-05 (68788765305)

Pricing Information	N/A
NDC Package Code	68788-7653-5
Billing NDC	68788765305
Package	15 TABLET in 1 BOTTLE (68788-7653-5)
Marketing Start Date	2020-02-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8cf58067-8805-423a-b1aa-cfe28641a215 Details

Active ingredient (in each tablet)

Loratadine 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. (1-800-222-1222)

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

•: do not use if printed foil under cap is broken or missing
•: store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the active ingredient of CLARITIN®

Non-Drowsy* - Allergy

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Loratadine Tablets, 10 mg/Antihistamine

Indoor & Outdoor Allergies

24 HOUR

Actual Size

24 Hour Relief of:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

NDC: 68788-7653

Repackaged by Preferred Pharmaceuticals, Inc.

INGREDIENTS AND APPEARANCE

LORATADINE

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-7653(NDC:0904-6852)
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68788-7653-0	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2020
2	NDC:68788-7653-1	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2020
3	NDC:68788-7653-5	15 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2020
4	NDC:68788-7653-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2020
5	NDC:68788-7653-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076301	02/28/2020

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-7653)

Revised: 8/2022

Document Id: e13262ad-5756-4568-9752-1507260deea6

Set id: 8cf58067-8805-423a-b1aa-cfe28641a215

Version: 3

Effective Time: 20220810