Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 7a3d416e-ccbe-4823-9c76-ee5b2001599e

Route

ORAL

Published

Effective Date 2013-03-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate Starch, Pregelatinized Corn

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-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

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

Principal Display Panel

MEDLINE

NDC 53329-651-33

^† Compare to the active ingredient in Claritin ^®

NON-DROWSY^*

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

ALLERGY RELIEF

Indoor & Outdoor Allergies

24 HOUR RELIEF of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 mg

30 Tablets

(When taken as directed. See Drug Facts Panel.)

Distributed by: Medline, Industries, Inc.

5099016/1012

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.

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-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MEDLINE

NDC 53329-651-33

^† Compare to the active ingredient in Claritin ^®

NON-DROWSY^*

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

ALLERGY RELIEF

Indoor & Outdoor Allergies

24 HOUR RELIEF of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 mg

30 Tablets

(When taken as directed. See Drug Facts Panel.)

Distributed by: Medline, Industries, Inc.

5099016/1012

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.

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": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "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-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST", "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", "PRINCIPAL DISPLAY PANEL": "MEDLINE NDC 53329-651-33 † Compare to the active ingredient in Claritin ® NON-DROWSY * LORATADINE TABLETS, USP 10 mg ANTIHISTAMINE ALLERGY RELIEF Indoor & Outdoor Allergies 24 HOUR RELIEF of: • Sneezing • Runny Nose • Itchy, Watery Eyes • I tchy Throat or Nose 10 mg 30 Tablets (When taken as directed. See Drug Facts Panel.) Distributed by: Medline, Industries, Inc. 5099016/1012", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:36.651176 · Updated: 2026-03-14T22:53:27.452907