DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Gelatin Type B Bovine (160 Bloom) Glycerin Glyceryl Mono- And Dicaprylocaprate Hypromellose 2910 (3 Mpa.s) Isopropyl Alcohol Fd&c Blue No. 1 Polysorbate 80 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: LR10 Shape: oval Color: blue Size: 11 mm Score: 1

Marketing Status

ANDA Active Since 2023-03-24

Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each capsule) Loratadine USP 10 mg

Uses

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

runny nose
sneezing
itchy, watery 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.

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

Drug Facts

Active ingredient

(in each capsule)

Loratadine USP 10 mg

Other Information

do not use if the individual blister unit is open or torn
store between 20° to 25°C (68° to 77°F)
protect from freezing
FDA approved dissolution test specifications differ from USP

Inactive Ingredients

Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

Questions Or Comments?

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

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.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Package Label Principal Display Panel 10 Mg (10 Capsule Blister Carton)

AUROHEALTH

NDC 58602-818-83

Compare to the active ingredient

in Claritin^® Liqui-Gels^®†

Non-Drowsy^*

Loratadine Capsules USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

24 HOUR

10 Liquid-Filled Capsules

*When taken as directed.

See Drug Facts Panel.

Structured Label Content

Uses

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

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Purpose

Antihistamine

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

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

Drug Facts

Active ingredient

(in each capsule)

Loratadine USP 10 mg

Other Information (Other information)

do not use if the individual blister unit is open or torn
store between 20° to 25°C (68° to 77°F)
protect from freezing
FDA approved dissolution test specifications differ from USP

Inactive Ingredients (Inactive ingredients)

Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Package Label Principal Display Panel 10 Mg (10 Capsule Blister Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton))

AUROHEALTH

NDC 58602-818-83

Compare to the active ingredient

in Claritin^® Liqui-Gels^®†

Non-Drowsy^*

Loratadine Capsules USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

24 HOUR

10 Liquid-Filled Capsules

*When taken as directed.

See Drug Facts Panel.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GELATIN TYPE B BOVINE (160 BLOOM)", "unii": "1T8387508X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONO- AND DICAPRYLOCAPRATE", "unii": "U72Q2I8C85", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (3 MPA.S)", "unii": "0VUT3PMY82", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat", "Purpose": "Antihistamine", "Warnings": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "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", "Drug Facts": "Active ingredient (in each capsule) Loratadine USP 10 mg", "Other information": "do not use if the individual blister unit is open or torn store between 20° to 25°C (68° to 77°F) protect from freezing FDA approved dissolution test specifications differ from USP", "Inactive ingredients": "Gelatin, glycerin, glyceryl monocaprylocaprate, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polysorbate 80, povidone, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.", "Questions or comments?": " call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009", "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.", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 Capsule Blister Carton)": "AUROHEALTH NDC 58602-818-83 Compare to the active ingredient in Claritin ® Liqui-Gels ®† Non-Drowsy * Loratadine Capsules USP 10 mg Antihistamine Indoor & Outdoor Allergies Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 24 HOUR 10 Liquid-Filled Capsules *When taken as directed. See Drug Facts Panel."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information