Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: GG296 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2018-10-30

Medication Information

Purpose

Antihistamine

Description

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

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

Do Not Use

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

Package Label

Loratadine 10 mg Tablets

Other Information

safety sealed: do not use if the printed bottle seal is open or torn
store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)

Inactive Ingredients

lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

Principal Display Panel

†Compare to the active ingredient in Claritin®

Loratadine tablets, USP

Antihistamine

10 mg

Non-drowsy*

Indoor & outdoor allergies

24-hour relief of

sneezing
itchy, watery eyes
runny nose
itchy throat or nose

100 Tablets

*When taken as directed. See Drug Facts panel

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®

Manufactured by:

Avema Pharm Solutions

10400 NW 29th Terrace, Miami, FL 33172

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.

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have

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

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

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

Do Not Use (Do not use)

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

Package Label

Loratadine 10 mg Tablets

Other Information (Other information)

safety sealed: do not use if the printed bottle seal is open or torn
store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)

Inactive Ingredients (Inactive ingredients)

lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST

Principal Display Panel

†Compare to the active ingredient in Claritin®

Loratadine tablets, USP

Antihistamine

10 mg

Non-drowsy*

Indoor & outdoor allergies

24-hour relief of

sneezing
itchy, watery eyes
runny nose
itchy throat or nose

100 Tablets

*When taken as directed. See Drug Facts panel

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin®

Manufactured by:

Avema Pharm Solutions

10400 NW 29th Terrace, Miami, FL 33172

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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine, USP 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.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Package Label": "Loratadine 10 mg Tablets", "Other information": "safety sealed: do not use if the printed bottle seal is open or torn store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)", "Inactive ingredients": "lactose monohydrate,magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9 AM-5 PM EST", "Principal Display Panel": "†Compare to the active ingredient in Claritin® Loratadine tablets, USP Antihistamine 10 mg Non-drowsy* Indoor & outdoor allergies 24-hour relief of sneezing itchy, watery eyes runny nose itchy throat or nose 100 Tablets *When taken as directed. See Drug Facts panel TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING †This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Claritin® Manufactured by: Avema Pharm Solutions 10400 NW 29th Terrace, Miami, FL 33172", "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.", "Active ingredient (in each tablet)": "Loratadine, USP 10 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information