Loratadine Tablets Usp 10 Mg

SPL v8

SPL

SPL Set ID 3937f769-e8e2-4b32-8338-21b0a74a8697

Route

ORAL

Published

Effective Date 2025-05-13

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Starch, Corn 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 2019-08-26

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° 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive,

Woonsocket, RI 02895

©2023 CVS/pharmacy

CVS.com^®

1-800-SHOP CVS

Made in India V-31735

100 % money back guaranteed.

CVS.com/returnpolicy

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.

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 10 Mg (90 Tablets Bottle)

^♥CVS

Health_®

NDC69842-242-19

Indoor & Outdoor Allergies

Non-Drowsy*

Allergy Relief

LORATADINE TABLETS U SP 10 mg

Antihistamine

24 Hours Relief of:

Sneezing; Runny nose;

Itchy, watery eyes;

Itchy throat or nose

*When taken as directed.

See Drug Facts Panel.

90 TABLETS

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

^♥CVS Health_™

Compare to the active

ingredient in Claritin ^® Tablets^†

Indoor & Outdoor Allergies

NDC 69842-242-91

Non-Drowsy*

Allergy Relief

LORATADINE TABLETS

USP 10 mg

Antihistamine

24

HOUR

Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

*When taken as directed.

See Drug Facts Panel.



30 TABLETS             Actual Size

Package Label Principal Display Panel 10 Mg Container Carton (90 Tablets)

^♥CVS

Health_®

Compare to the active

ingredient in Claritin^® Tablets^†

Indoor & Outdoor Allergies

NDC 69842-242-19

Non-Drowsy*

Allergy Relief

LORATADINE TABLETS

USP 10 mg

Antihistamine

24 Hour

Relief of:

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

Actual Bottle Size

on Side Panel

*When taken as directed.

See Drug Facts Panel.

Actual Size

90 TABLETS             Actual Bottle Size

                                    on Side 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

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 (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° 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?)

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.

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 10 Mg (90 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (90 Tablets Bottle))

*When taken as directed.

See Drug Facts Panel.

90 TABLETS

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

^♥CVS Health_™

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

*When taken as directed.

See Drug Facts Panel.



30 TABLETS             Actual Size

Package Label Principal Display Panel 10 Mg Container Carton (90 Tablets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (90 Tablets))

Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose

Actual Bottle Size

on Side Panel

*When taken as directed.

See Drug Facts Panel.

Actual Size

90 TABLETS             Actual Bottle Size

                                    on Side Panel

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": "STARCH, CORN", "unii": "O8232NY3SJ", "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 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° 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 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 ©2023 CVS/pharmacy CVS.com ® 1-800-SHOP CVS Made in India V-31735 100 % money back guaranteed. CVS.com/returnpolicy 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.", "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 - 10 mg (90 Tablets Bottle)": "♥ CVS Health ® NDC69842-242-19 Indoor & Outdoor Allergies Non-Drowsy * Allergy Relief LORATADINE TABLETS U SP 10 mg Antihistamine 24 Hours Relief of: Sneezing; Runny nose; Itchy, watery eyes; Itchy throat or nose *When taken as directed. See Drug Facts Panel. 90 TABLETS", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)": "♥ CVS Health ™ Compare to the active ingredient in Claritin ® Tablets † Indoor & Outdoor Allergies NDC 69842-242-91 Non-Drowsy* Allergy Relief LORATADINE TABLETS USP 10 mg Antihistamine 24 HOUR Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose *When taken as directed. See Drug Facts Panel. 30 TABLETS Actual Size", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (90 Tablets)": "♥ CVS Health ® Compare to the active ingredient in Claritin ® Tablets † Indoor & Outdoor Allergies NDC 69842-242-19 Non-Drowsy* Allergy Relief LORATADINE TABLETS USP 10 mg Antihistamine 24 Hour Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose Actual Bottle Size on Side Panel *When taken as directed. See Drug Facts Panel. Actual Size 90 TABLETS Actual Bottle Size on Side Panel "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.476752 · Updated: 2026-03-14T23:08:44.584027