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NDC 51660-0527-31 Allergy Relief 10 mg/1 Details

Allergy Relief 10 mg/1

Allergy Relief is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories 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: 51660-0527-31
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	51660-0527
Product ID	51660-527_7b87d8ea-1102-4642-8a39-b2504dbda716
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	Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Ohm Laboratories Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077153
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51660-0527-31 (51660052731)

Pricing Information	N/A
NDC Package Code	51660-527-31
Billing NDC	51660052731
Package	30 BLISTER PACK in 1 CARTON (51660-527-31) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2007-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL de3a7725-5d1b-4195-a9f8-43f92888997c 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
•: 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

•: place 1 tablet on tongue; tablet disintegrates, with or without water

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

•: Phenylketonurics: Contains Phenylalanine 0.6 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). Protect from excessive moisture.
•: use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

†Compare To the active ingredient of Claritin® RediTabs®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY*

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

: • Melts in Your Mouth

24 HOUR

Relief of:

•: Sneezing
•: Itchy, Watery Eyes
•: Runny Nose
•: Itchy Throat or Nose

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

5217818/R0321

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-527
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
MANNITOL (UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ASPARTAME (UNII: Z0H242BBR1)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (flat face beveled edged)	Size	10mm
Flavor	STRAWBERRY, TUTTI FRUTTI, MINT	Imprint Code	RC17
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51660-527-31	30 in 1 CARTON	08/31/2007
1		1 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	ANDA077153	08/31/2007

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Ohm Laboratories Inc. (051565745)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	MANUFACTURE(51660-527)

Revised: 4/2021

Document Id: 7b87d8ea-1102-4642-8a39-b2504dbda716

Set id: de3a7725-5d1b-4195-a9f8-43f92888997c

Version: 6

Effective Time: 20210406