LORATADINE- loratadine tablet

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

Buy It Now

Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
AvPAK
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 liver or kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away.
Authorization status:
Abbreviated New Drug Application
Authorization number:
50268-489-11, 50268-489-15

LORATADINE- loratadine tablet

AvPAK

----------

Loratadine Tablets USP 10 mg

Drug Facts

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 (1-800-222-1222) 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

Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR

PROTECTION” is missing, open or broken

store at 20° to 25°C (68° to 77°F)

protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

call 1-855-361-3993

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

LORATADINE

loratadine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 26 8 -48 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AvPAK

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 )

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

white (White to Off-white)

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

39 ;L

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 26 8 -48 9 -15

50 in 1 BOX

0 5/28 /20 19

1

NDC:50 26 8 -48 9 -11

1 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

ANDA20 8 314

0 5/28 /20 19

Labeler -

AvPAK (832926666)

Revised: 5/2019

Similar products

Search alerts related to this product

View documents history

Share this information