Topco Associates Llc. Allergy Relief Liquid-gels Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Hypromellose, Unspecified Isopropyl Alcohol Mannitol Glyceryl Mono- And Dicaprylocaprate Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 446 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2020-08-02

Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information

•
do not use if blister unit is broken or torn
•
store between 20° to 25°C (68° to 77°F)
•
protect from freezing
•
meets USP dissolution test 2

Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

1-888-423-0139

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).

Active Ingredient (in Each Capsule)

Loratadine 10 mg

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

TopCare_® health

COMPARE TO CLARITIN^® LIQUI-GELS^® ACTIVE INGREDIENT

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief Liquid-Gels

LORATADINE CAPSULES, 10 mg • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

LIQUID-GELS

actual size

30 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
•
itchy, watery eyes
•
sneezing
•
itching of the nose or throat

Purpose

Antihistamine

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (Other information)

•
do not use if blister unit is broken or torn
•
store between 20° to 25°C (68° to 77°F)
•
protect from freezing
•
meets USP dissolution test 2

Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 right away (1-800-222-1222).

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Loratadine 10 mg

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 (Package/Label Principal Display Panel)

TopCare_® health

COMPARE TO CLARITIN^® LIQUI-GELS^® ACTIVE INGREDIENT

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief Liquid-Gels

LORATADINE CAPSULES, 10 mg • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

LIQUID-GELS

actual size

30 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": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONO- AND DICAPRYLOCAPRATE", "unii": "U72Q2I8C85", "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": "SORBITAN", "unii": "6O92ICV9RU", "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 • itchy, watery eyes • sneezing • itching of the nose or throat", "Purpose": "Antihistamine", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Other information": "• do not use if blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • protect from freezing • meets USP dissolution test 2", "Inactive ingredients": "FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide", "Questions or comments?": "1-888-423-0139", "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).", "Active ingredient (in each capsule)": "Loratadine 10 mg", "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": "TopCare ® health COMPARE TO CLARITIN ® LIQUI-GELS ® ACTIVE INGREDIENT NON-DROWSY* ORIGINAL PRESCRIPTION STRENGTH Allergy Relief Liquid-Gels LORATADINE CAPSULES, 10 mg • ANTIHISTAMINE INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: ● Sneezing ● Runny Nose ● Itchy, Watery Eyes ● Itchy Throat or Nose LIQUID-GELS actual size 30 LIQUID-FILLED CAPSULES *When taken as directed. See Drug Facts Panel."}

Topco Associates Llc. Allergy Relief Liquid-gels Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information