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NDC 60760-0569-00 Allergy Relief 10 mg/1 Details

Allergy Relief 10 mg/1

Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by St Mary's Medical Park Pharmacy. 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: 60760-0569-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	60760-0569
Product ID	60760-569_de5f9641-49c4-490a-e053-2a95a90af219
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	Allergy Relief
Proprietary Name Suffix	Non drowsy
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	St Mary's Medical Park Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075209
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60760-0569-00 (60760056900)

Pricing Information	N/A
NDC Package Code	60760-569-00
Billing NDC	60760056900
Package	100 TABLET in 1 BOTTLE, PLASTIC (60760-569-00)
Marketing Start Date	2022-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de5fa19f-25d9-ba81-e053-2a95a90af82f Details

Active ingredient (in each tablet)

Loratadine, USP 10 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 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 (1-800-222-1222) 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 or kidney disease	ask a doctor

Other information

store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
protect from light

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Claritin® 24 Hour

Non-drowsy*

Allergy Relief

Loratadine Tablets, USP 10 mg / Antihistamine

Indoor & outdoor allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

Tablets

Gluten-Free

* When taken as directed. See Drug Facts panel.

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® 24 Hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING.

Distributed by:

Camber Consumer Care Inc., Piscataway, NJ 08854, USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF NON DROWSY

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-569(NDC:69230-317)
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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	439
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60760-569-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075209	12/27/2019

Labeler - St Mary's Medical Park Pharmacy (063050751)

Name	Address	ID/FEI	Business Operations
Establishment
St Mary's Medical Park Pharmacy		063050751	relabel(60760-569) , repack(60760-569)

Revised: 5/2022

Document Id: de5f9641-49c4-490a-e053-2a95a90af219

Set id: de5fa19f-25d9-ba81-e053-2a95a90af82f

Version: 3

Effective Time: 20220505