LORATADINE- loratadine tablet, chewable

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
PUBLIX SUPER MARKETS INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Authorization status:
Abbreviated New Drug Application
Authorization number:
56062-990-20

LORATADINE- loratadine tablet, chewable

PUBLIX SUPER MARKETS INC

----------

LORATADINE

Drug Facts

Active ingredient (in each tablet)

Loratadine USP, 5 mg

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.

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 (1-800-222-1222).

Directions

chew or crush tablets completely before swallowing.

adults and children 6

years and over

chew 2 tablets daily; not more than 2

tablets in 24 hours

children 2 to under 6

years of age

chew 1 tablet daily; not more than 1

tablet in 24 hours

children under 2 years

of age

ask a doctor

consumers with liver or

kidney disease

ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR

SHOW ANY SIGNS OF TAMPERING.

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

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue

No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch

glycolate, stearic acid

DISTRIBUTED BY

PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 56062-990-20

FOR AGES 2 YEARS AND OLDER

INDOOR & OUTDOOR ALLERGIES

children's allergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*

24-hour relief of:

Sneezing Runny nose

Itchy, watery eyes Itchy throat or nose

ACTUAL

SIZE

CHEWABLE

TABLETS

The chewable tablets are to be chewed before swallowing.

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

Compare to the active ingredient

of Children's Claritin Chewables

LORATADINE

loratadine tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-9 9 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

LORATADINE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

D&C RED NO . 2 7 (UNII: 2LRS18 5U6 K)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

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

MANNITO L (UNII: 3OWL53L36 A)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

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

Product Characteristics

Color

PURPLE (light purple to dark purple)

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:56 0 6 2-9 9 0 -

2 in 1 CARTON

0 7/31/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA210 0 8 8

0 7/31/20 19

PUBLIX SUPER MARKETS INC

Labeler -

PUBLIX SUPER MARKET S INC (006922009)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ohm Labo rato ries Inc.

18 476 9 0 29

MANUFACTURE(56 0 6 2-9 9 0 )

Revised: 8/2019

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