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NDC 00113-1612-95 good sense allergy relief 10 mg/1 Details

good sense allergy relief 10 mg/1

good sense allergy relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo 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: 00113-1612-95
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	00113-1612
Product ID	0113-1612_bf838a8e-a12d-4970-8613-56a8b1864f33
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	good sense 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	L. Perrigo Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076301
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00113-1612-95 (00113161295)

Pricing Information	N/A
NDC Package Code	0113-1612-95
Billing NDC	00113161295
Package	1 BOTTLE in 1 CARTON (0113-1612-95) / 45 TABLET in 1 BOTTLE
Marketing Start Date	2018-09-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 74bed4ad-5afe-4293-bef3-e0b9d5f64a29 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

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Original Prescription Strength

Allergy Relief

Actual Size

Loratadine Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

45 Tablets

Compare to active ingredient of Claritin® Tablets

100% SATISFACTION GUARANTEED

INGREDIENTS AND APPEARANCE

GOOD SENSE ALLERGY RELIEF

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0113-1612
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:0113-1612-95	1 in 1 CARTON	09/26/2018
1		45 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076301	09/26/2018

Labeler - L. Perrigo Company (006013346)

Revised: 12/2019

Document Id: bf838a8e-a12d-4970-8613-56a8b1864f33

Set id: 74bed4ad-5afe-4293-bef3-e0b9d5f64a29

Version: 2

Effective Time: 20191205