drug facts

drug facts
SPL v1
SPL
SPL Set ID e1b671ec-5770-47e9-8d72-cc4fe2eab259
Route
oral
Published
Effective Date 2012-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loratadine (10 mg)
Inactive Ingredients
lactose monohydrate magnesium stearate starch, corn 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

Purpose

Antihistamine

Description

Loratadine USP, 10 mg


Medication Information

Active Ingredient

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
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

Other Information
  • 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.
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Description

Loratadine USP, 10 mg

Principal Display Panel

The Medicine Shoppe ®

NDC 49614-170-75

Non-Drowsy *

Original Prescription Strength

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

* When taken as directed. See Drug Facts Panel.

90 TABLETS

Compare to Claritin ® active ingredient

This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin ® .

Questions?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

1800-325-1397

Do Not Use

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

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.


Structured Label Content

Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

Loratadine USP, 10 mg

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

Other Information (OTHER INFORMATION)
  • 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.
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
Inactive Ingredients (INACTIVE INGREDIENTS)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

The Medicine Shoppe ®

NDC 49614-170-75

Non-Drowsy *

Original Prescription Strength

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Allergy Relief

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

* When taken as directed. See Drug Facts Panel.

90 TABLETS

Compare to Claritin ® active ingredient

This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Claritin ® .

Questions? (QUESTIONS?)

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by

Medicine Shoppe International, Inc.

Earth City, MO 63045

www.medicineshoppe.com

1800-325-1397

Do Not Use (Do not use)

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

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.


Advanced Ingredient Data


Raw Label Data

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