MOORE MEDICAL LORATADINE- loratadine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
Moore Medical LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
55670-478-46, 55670-478-50

MOORE MEDICAL LORATADINE- loratadine tablet, film coated

Moore Medical LLC

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Moore Medical Loratadine

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 (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease Ask a doctor before using.

Other information

tamper evident sealed packets

do not use any opoened or torn packets

store between 68º and 77ºF (20º and 25ºC)

protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

Call 1-800.234.1464

Moore Medical Loratadine Label

mooremedical

Supporting Health & Care

Reorder No. 82478

UPN# 0-0607415-82478-0

MooreBrand®

Loratadine

50 Packets/ 1 Tablet

Relieves sneezing, runny nose, itching and watering of the eyes

due to upper respiratory allergies.

Packet is not child resistant

Pull to Open

MOORE MEDICAL LORATADINE

loratadine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:556 70 -478

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

LORATADINE

10 mg

Moore Medical LLC

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

LORATADINE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

STARCH, CO RN (UNII: O8 232NY3SJ)

Product Characteristics

Color

white (white)

S core

no sco re

S hap e

ROUND (ROUND)

S iz e

6 mm

Flavor

Imprint Code

RX;526

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:556 70 -478 -50

50 in 1 BOX

12/30 /20 0 8

1

NDC:556 70 -478 -46

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 134

12/30 /20 0 8

Labeler -

Moore Medical LLC (051420107)

Revised: 6/2020

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