Loratadine Tablets Usp 10mg

SPL v4

SPL

SPL Set ID adc506ed-7a7a-facc-e053-2a95a90ae147

Route

ORAL

Published

Effective Date 2020-08-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Magnesium Stearate Starch, Corn Lactose Monohydrate Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: 39;L Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2020-08-26

Description

Loratadine USP 10 mg

Purpose

Antihistamine

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

itchy, watery eyes

sneezing

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 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

Other Information

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

store at 20°C to 25°C (68° to 77°F)

protect from excessive moisture

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions Or Comments?

call 1-855-274-4122

Manufactured by: Aurobindo Pharma Limited

Hyderabad-509 302,

INDIA

For BluePoint Laboratories

MADE IN INDIA

Code: TS/DRUGS/22/2009

Issued: 04/2020

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 an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

Package Label Principal Display Panel 10mg (100 Tablets Bottle)

NDC 68001-438-00

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

^#When taken as directed.

See Drug Facts Panel. 100 Tablets

Package Label Principal Display Panel 10 Mg Blister Carton (100 Tablets)

NDC 68001-438-96

#Compare to the active

ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 100 Tablets

Package Label Principal Display Panel 10 Mg Container Carton (30 Tablets)

NDC 68001-438-04

^#Compare to the active ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 30 Tablets

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

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 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

Other Information

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

store at 20°C to 25°C (68° to 77°F)

protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Manufactured by: Aurobindo Pharma Limited

Hyderabad-509 302,

INDIA

For BluePoint Laboratories

MADE IN INDIA

Code: TS/DRUGS/22/2009

Issued: 04/2020

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 an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.

Package Label Principal Display Panel 10mg (100 Tablets Bottle) (PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg (100 Tablets Bottle))

NDC 68001-438-00

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

^#When taken as directed.

See Drug Facts Panel. 100 Tablets

Package Label Principal Display Panel 10 Mg Blister Carton (100 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 10 mg Blister Carton (100 Tablets))

NDC 68001-438-96

#Compare to the active

ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 100 Tablets

Package Label Principal Display Panel 10 Mg Container Carton (30 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (30 Tablets))

NDC 68001-438-04

^#Compare to the active ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 30 Tablets

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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 itchy, watery eyes sneezing 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 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", "Other Information": "Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken store at 20°C to 25°C (68° to 77°F) protect from excessive moisture", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.", "Questions or comments?": "call 1-855-274-4122 Manufactured by: Aurobindo Pharma Limited Hyderabad-509 302, INDIA For BluePoint Laboratories MADE IN INDIA Code: TS/DRUGS/22/2009 Issued: 04/2020", "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 an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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.", "PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg (100 Tablets Bottle)": "NDC 68001-438-00 Non-Drowsy* Loratadine Tablets USP 10mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies # When taken as directed. See Drug Facts Panel. 100 Tablets", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 10 mg Blister Carton (100 Tablets)": "NDC 68001-438-96 #Compare to the active ingredient in claritin® Non-Drowsy* Loratadine Tablets USP 10mg Antihisamine Indoor and outdoor allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. 100 Tablets", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (30 Tablets)": "NDC 68001-438-04 # Compare to the active ingredient in claritin® Non-Drowsy* Loratadine Tablets USP 10mg Antihisamine Indoor and outdoor allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. 30 Tablets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:14.732538 · Updated: 2026-03-14T23:00:37.728626