Non-Drowsy*Claritin ® loratadine tablets 10 mg/antihistamine

Claritin by

Drug Labeling and Warnings

Claritin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLARITIN- loratadine tablet 
REMEDYREPACK INC.

----------

Non-Drowsy*Claritin ®

loratadine tablets 10 mg/antihistamine

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

CLARITIN 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-2951(NDC: 11523-7160)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-2951-0	1 in 1 CARTON	12/01/2020	10/16/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019658	12/01/2020	10/16/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: 07d76684-6cb5-a4d4-e063-6394a90a2042

34390-5

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

Version: 3

Effective Time: 20231016