ALLERGY RELIEF- loratadine capsule, liquid filled

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

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
GOODSENSE
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 • sneezing • itchy, water eyes • itching of the nose or throat
Authorization status:
Abbreviated New Drug Application
Authorization number:
50804-840-10

ALLERGY RELIEF- loratadine capsule, liquid filled

GOODSENSE

----------

GDS - 1195A - 2019-0917

Drug Facts

Active Ingredient (in each capsule)

Loratadine 10mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

runny nose

sneezing

itchy, water eyes

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

adults and children 6 years and over

1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)

protect from freezing

retain carton for complete information and warnings

Inactive ingredients

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink,

polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Questions or comments?

Questions or Comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

GOODSENSE®

NDC 50804-840-10

Non-Drowsy*

Allergy Relief

Loratadine Capsules, 10mg / Antihistamine

Indoor & Outdoor Allergies

Actual Size

24 Hour

Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose

Compare to the active ingredient of Claritin® Liqui-Gels®

100% SATISFACTION GUARANTEED

10 SOFTGELS**

(**Liquid-Filled Capsules)

ALLERGY RELIEF

loratadine capsule, liquid filled

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 8 0 4-8 40

Route of Administration

ORAL

GOODSENSE

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

GELATIN (UNII: 2G8 6 QN327L)

CAPRIC ACID (UNII: 4G9 EDB6 V73)

PO VIDO NE K3 0 (UNII: U725QWY32X)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO RBITAN (UNII: 6 O9 2ICV9 RU)

Product Characteristics

Color

blue (Light Blue)

S core

no sco re

S hap e

OVAL (o val shaped)

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:50 8 0 4-8 40 -

1 in 1 CARTON

12/0 1/20 18

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

ANDA20 6 214

12/0 1/20 18

Labeler -

GOODSENSE (076059836)

Revised: 9/2019

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