Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 506a60e8-7fec-4bb0-babc-204058ae120f
Route
ORAL
Published
Effective Date 2018-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2003-08-28

Description

Loratadine, USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine, USP 10 mg

Use(s)

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 and 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?

or to report an adverse event call 800-824-7984 Monday - Friday 9am - 4pm MST

Other Information
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.
Active Ingredient(s)

Loratadine, USP 10 mg

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 (1-800-222-1222).

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 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®

†When taken as directed. See Drug Facts Panel.

WinCo™

FOODS

24 HOUR

NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,

USP 10 mg/ANTIHISTAMINE

Original

Prescription Strength

Relief of: Sneezing,

Runny Nose,

Itchy, Watery Eyes &

Itchy Throat or Nose

10

Tablets

Principal Display Panel 30 Tablet Blister Pack Carton

*Compare to the active ingredient in CLARITIN®

†When taken as directed. See Drug Facts Panel.

WinCo™

FOODS

24 HOUR

NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,

USP 10 mg/ANTIHISTAMINE

Original

Prescription Strength

Relief of: Sneezing,

Runny Nose,

Itchy, Watery Eyes &

Itchy Throat or Nose

30

Tablets


Structured Label Content

Use(s) (USE(S))

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 and 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?)

or to report an adverse event call 800-824-7984 Monday - Friday 9am - 4pm MST

Other Information (OTHER INFORMATION)
  • store between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW AN SIGN OF TAMPERING.
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Loratadine, USP 10 mg

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 (1-800-222-1222).

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 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton)

*Compare to the active ingredient in CLARITIN®

†When taken as directed. See Drug Facts Panel.

WinCo™

FOODS

24 HOUR

NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,

USP 10 mg/ANTIHISTAMINE

Original

Prescription Strength

Relief of: Sneezing,

Runny Nose,

Itchy, Watery Eyes &

Itchy Throat or Nose

10

Tablets

Principal Display Panel 30 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton)

*Compare to the active ingredient in CLARITIN®

†When taken as directed. See Drug Facts Panel.

WinCo™

FOODS

24 HOUR

NON-DROWSY

Allergy Relief

Indoor & Outdoor Allergies

LORATADINE TABLETS,

USP 10 mg/ANTIHISTAMINE

Original

Prescription Strength

Relief of: Sneezing,

Runny Nose,

Itchy, Watery Eyes &

Itchy Throat or Nose

30

Tablets


Advanced Ingredient Data


Raw Label Data

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