Guardian Loratadine Tablets

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2019-07-22

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10mg

Use(s)

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

.

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.

Other Information

Store at 20^o to 25^oC (68^o to 77^oF) [See USP Controlled Room Temperature]
Protect from excessive moisture

SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

Questions Or Comments?

call 1-609-860-2600 Hours: 8am-4pm, EST.

Principal Display Panel

Guardian

NDC 53041-285-21

Non-Drowsy*

Original Prescription Strength

Loratadine

Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat Or Nose

When Using This Product

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

Stop Use and Ask Doctor If

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

If Pregnant Or Breastfeeding,

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, 10mg

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

Use(s) (USE(S))

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 (PURPOSE)

Antihistamine

Warnings (WARNINGS)

.

Directions (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.

Other Information (OTHER INFORMATION)

Store at 20^o to 25^oC (68^o to 77^oF) [See USP Controlled Room Temperature]
Protect from excessive moisture

SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN

Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call 1-609-860-2600 Hours: 8am-4pm, EST.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Guardian

NDC 53041-285-21

Non-Drowsy*

Original Prescription Strength

Loratadine

Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat Or Nose

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 Doctor If (STOP USE AND ASK DOCTOR IF)

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

If Pregnant Or Breastfeeding, (IF PREGNANT OR BREASTFEEDING,)

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, 10mg

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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "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": ".", "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.", "OTHER INFORMATION": "Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature] Protect from excessive moisture SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN ", "INACTIVE INGREDIENTS": "colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate", "QUESTIONS OR COMMENTS?": "call 1-609-860-2600 Hours: 8am-4pm, EST.", "PRINCIPAL DISPLAY PANEL": "Guardian NDC 53041-285-21 Non-Drowsy* Original Prescription Strength Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat Or Nose", "WHEN USING THIS PRODUCT": "do not take more than directed. Taking more than directed may cause drowsiness.", "STOP USE AND ASK DOCTOR IF": "an allergic reaction to this product occurs. Seek medical help right away.", "IF PREGNANT OR BREASTFEEDING,": "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, 10mg", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "liver or kidney disease. Your doctor should determine if you need a different dose. "}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information