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NDC 70518-2951-00 Claritin 10 mg/1 Details

Claritin 10 mg/1

Claritin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-2951-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	70518-2951
Product ID	70518-2951_d79be82a-1bed-d2b0-e053-2995a90ab00f
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	Claritin
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	REMEDYREPACK INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019658
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2951-00 (70518295100)

Pricing Information	N/A
NDC Package Code	70518-2951-0
Billing NDC	70518295100
Package	1 BLISTER PACK in 1 CARTON (70518-2951-0) / 10 TABLET in 1 BLISTER PACK
Marketing Start Date	2020-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ef32c567-e14e-4b07-ab48-44850b3c14ea Details

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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 (Blister foil units)

safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Other information (Bottles)

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or comments?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Claritin

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2951-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 458;Claritin10

PACKAGING: 10 in 1 BLISTER PACK

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

STARCH, CORN
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE

INGREDIENTS AND APPEARANCE

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2951(NDC:11523-7160)
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
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70518-2951-0	1 in 1 CARTON	12/01/2020
1		10 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
NDA	NDA019658	12/01/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 2/2022

Document Id: d79be82a-1bed-d2b0-e053-2995a90ab00f

Set id: ef32c567-e14e-4b07-ab48-44850b3c14ea

Version: 2

Effective Time: 20220209