Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a4a4a50e-f640-4a95-a317-e988edc22db5
Route
ORAL
Published
Effective Date 2012-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Starch, Corn Starch, Pregelatinized 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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

SUPERVALU INC.

Eden Prairie, MN 55344 USA

1-877-932-7948

www.supervalu-ourownbrands.com

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.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

equaline ®

NDC 41163-526-90

non-drowsy *

allergy relief

loratadine tablets USP, 10 mg/antihistamine

indoor & outdoor allergies

24 hour relief of:

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat or nose

original prescription strength

90 tablets

* When taken as directed. See drug facts panel.

compare to Claritin ® Tablets active ingredient **

** This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ® is a registered trademark of Schering Corporation.

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 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

SUPERVALU INC.

Eden Prairie, MN 55344 USA

1-877-932-7948

www.supervalu-ourownbrands.com

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.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

equaline ®

NDC 41163-526-90

non-drowsy *

allergy relief

loratadine tablets USP, 10 mg/antihistamine

indoor & outdoor allergies

24 hour relief of:

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat or nose

original prescription strength

90 tablets

* When taken as directed. See drug facts panel.

compare to Claritin ® Tablets active ingredient **

** This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN ® is a registered trademark of Schering Corporation.

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


Raw Label Data

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