ALLERGY RELIEF- loratadine tablet

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
First Aid Direct
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:
53117-407-85

ALLERGY RELIEF- loratadine tablet

First Aid Direct

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309 - Health A2Z Allergy Relief

Active ingredient

Loratadine 10mg

Purpos e

Antihistamine

Us es

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.

Pregnancy/Breas tfeeding

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control

Center immediately.

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

store between 20° to 25°C (68° to 77°F)

protect from excessive moisture

do not use if blister unit is torn or open

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Principal Display Panel

Non-Drowsy Allerg y Relief

ALLERGY RELIEF

loratadine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:53117-40 7

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

Inactive Ingredients

Ingredient Name

Stre ng th

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

6 mm

Flavor

Imprint Code

LOR10

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:53117-40 7-8 5 2 in 1 CARTON

12/16 /20 14

1

10 in 1 BLISTER PACK; 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 76 471

12/16 /20 14

Labeler -

First Aid Direct (962283128)

First Aid Direct

Revised: 9/2019

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