Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 7eac9202-bd4c-4550-a257-2b8195a0dbcd
Route
ORAL
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: 439 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2023-10-01
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
  • sneezing
  • itchy, watery eyes
  • 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.

Package Label
REXALL Non-Drowsy Allergy Relief
Other Information
  • store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)
  • protect from light
Inactive Ingredient

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

Call toll free 1-866-4-REXALL

Principal Display Panel

NON-DROWSY*

Allergy Relief

Loratadine Tablets, 10 mg/Antihistamine

24-hour relief of

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

Indoor & Outdoor allergies

GLUTEN FREE

Original Prescription Strength

*When taken as directed, see drug facts panel.

Tablets

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Package Label
REXALL Non-Drowsy Allergy Relief
Other Information (Other information)
  • store at 20º-25ºC (68º-77ºF) (see USP Controlled Room Temperature)
  • protect from light
Inactive Ingredient (Inactive ingredient)

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

Call toll free 1-866-4-REXALL

Principal Display Panel

NON-DROWSY*

Allergy Relief

Loratadine Tablets, 10 mg/Antihistamine

24-hour relief of

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

Indoor & Outdoor allergies

GLUTEN FREE

Original Prescription Strength

*When taken as directed, see drug facts panel.

Tablets

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.456508 · Updated: 2026-03-14T23:01:55.379030