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NDC 81522-0612-75 caring mill allergy relief 10 mg/1 Details

caring mill allergy relief 10 mg/1

caring mill allergy relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store 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: 81522-0612-75
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	81522-0612
Product ID	81522-612_ec53b677-42ac-4bad-8d56-52d2831cb4eb
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	caring mill 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	FSA Store Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076301
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81522-0612-75 (81522061275)

Pricing Information	N/A
NDC Package Code	81522-612-75
Billing NDC	81522061275
Package	1 BOTTLE in 1 CARTON (81522-612-75) / 90 TABLET in 1 BOTTLE
Marketing Start Date	2021-07-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c45fef08-4ac5-49f3-979f-06733059a586 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

Allergy Relief

Loratadine Tablets, 10 mg

Antihistamine

24 Hour

24 Hour relief of:

- Sneezing – Runny nose

- Itchy, watery eyes – Itchy throat or nose

Non drowsy*

Original prescription strength

Indoor & outdoor allergies

Actual Size

90 Tablets

*When taken as directed. See Drug Facts Panel.

90 days of relief

INGREDIENTS AND APPEARANCE

CARING MILL ALLERGY RELIEF

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81522-612
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:81522-612-75	1 in 1 CARTON	07/27/2021
1		90 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	07/27/2021

Labeler - FSA Store Inc. (049283340)

Revised: 8/2021

Document Id: ec53b677-42ac-4bad-8d56-52d2831cb4eb

Set id: c45fef08-4ac5-49f3-979f-06733059a586

Version: 2

Effective Time: 20210805