Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 11bc027c-d28d-45f0-a4cb-24a3834a6995

Route

ORAL

Published

Effective Date 2018-01-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2017-09-01

Description

Loratadine USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Use(s)

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

Section 42229-5

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

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 and 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 between 20 and 25° C (68 and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Active Ingredient(s)

Loratadine USP, 10 mg

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments?

1-877-753-3935

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.

Ask A Doctor Before Use If You Have

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

Principal Display Panel 10 Mg Tablet Blister Pack Carton

NON-DROWSY* NDC 71141-132-32

Original Prescription Strength

^†Compare to the active

ingredient in Claritin^®

Actual Size

Loratadine

Tablets,

USP 10 mg

Antihistamine

ALLERGY RELIEF

24 Hour

Relief of:

▶
Sneezing
▶
Runny Nose
▶
Itchy, Watery Eyes
▶
Itchy Throat or Nose

10 tablets

INDOOR &

OUTDOOR ALLERGIES

*When taken as directed. See Drugs Facts Panel.

Structured Label Content

Use(s) (USE(S))

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

Section 42229-5 (42229-5)

DISTRIBUTED BY

Lidl US, LLC

3500 S. Clark Street

Arlington, VA 22202

Purpose (PURPOSE)

Antihistamine

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 and 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 between 20 and 25° C (68 and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Loratadine USP, 10 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions Or Comments? (Questions or Comments?)

1-877-753-3935

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.

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.

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

NON-DROWSY* NDC 71141-132-32

Original Prescription Strength

^†Compare to the active

ingredient in Claritin^®

Actual Size

Loratadine

Tablets,

USP 10 mg

Antihistamine

ALLERGY RELIEF

24 Hour

Relief of:

▶
Sneezing
▶
Runny Nose
▶
Itchy, Watery Eyes
▶
Itchy Throat or Nose

10 tablets

INDOOR &

OUTDOOR ALLERGIES

*When taken as directed. See Drugs Facts Panel.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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 itchy, watery eyes sneezing itching of the nose or throat", "42229-5": "DISTRIBUTED BY Lidl US, LLC 3500 S. Clark Street Arlington, VA 22202", "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 and 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 between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.", "ACTIVE INGREDIENT(S)": "Loratadine USP, 10 mg", "INACTIVE INGREDIENTS": "Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "Questions or Comments?": "1-877-753-3935", "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.", "Ask a doctor before use if you have": "Liver or kidney disease. Your doctor should determine if you need a different dose.", "PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton": "NON-DROWSY* NDC 71141-132-32 Original Prescription Strength † Compare to the active ingredient in Claritin ® Actual Size Loratadine Tablets, USP 10 mg Antihistamine ALLERGY RELIEF 24 Hour Relief of: ▶ Sneezing ▶ Runny Nose ▶ Itchy, Watery Eyes ▶ Itchy Throat or Nose 10 tablets INDOOR & OUTDOOR ALLERGIES *When taken as directed. See Drugs Facts Panel."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:29.171741 · Updated: 2026-03-14T22:54:59.525683