Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 0cd920b4-b15a-4ca9-87e2-4dd523c6d1f8

Route

ORAL

Published

Effective Date 2018-08-28

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 2003-08-19

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

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.

Questions?

Call 1-800-406-7984

Other Information

store between 20 and 25° C (68 and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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.

Principal Display Panel 10 Mg Tablet Blister Pack Carton

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN^®*

Best

Choice^®

Non-Drowsy^†

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

Loratadine Tablets, USP 10 mg

ANTIHISTAMINE

24 Hour Allergy Relief

Indoor & Outdoor Allergies

Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

10 TABLETS

^† When taken as directed. See Drug Facts Panel.

Structured Label Content

Uses (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 (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 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.

Questions? (QUESTIONS?)

Call 1-800-406-7984

Other Information (OTHER INFORMATION)

store between 20 and 25° C (68 and 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

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.

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

COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN^®*

Best

Choice^®

Non-Drowsy^†

ORIGINAL PRESCRIPTION STRENGTH

ALLERGY RELIEF

Loratadine Tablets, USP 10 mg

ANTIHISTAMINE

24 Hour Allergy Relief

Indoor & Outdoor Allergies

Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

10 TABLETS

^† When taken as directed. See Drug 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)

{"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", "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.", "QUESTIONS?": "Call 1-800-406-7984", "OTHER INFORMATION": "store between 20 and 25° C (68 and 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "INACTIVE INGREDIENTS": "Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "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.", "PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton": "COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN ®* Best Choice ® Non-Drowsy † ORIGINAL PRESCRIPTION STRENGTH ALLERGY RELIEF Loratadine Tablets, USP 10 mg ANTIHISTAMINE 24 Hour Allergy Relief Indoor & Outdoor Allergies Relief of: Sneezing Itchy, Watery Eyes Runny Nose Itchy Throat or Nose 10 TABLETS † When taken as directed. See Drug Facts Panel."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:37.722404 · Updated: 2026-03-14T22:55:14.803903