Loratadine Tablets, 10 Mg

Loratadine Tablets, 10 Mg
SPL v5
SPL
SPL Set ID 9bae1ba3-c0da-23a2-e053-2a95a90a58ed
Route
ORAL
Published
Effective Date 2020-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Magnesium Stearate Sodium Starch Glycolate Type A Potato Anhydrous Lactose Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2020-01-08

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 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
Section 51945-4

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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

Active Ingredient

Loratadine 10 mg

Other Information
  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Ask A Doctor Before Use If

you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use and Ask 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.


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
Section 51945-4 (51945-4)

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

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

Active Ingredient (ACTIVE INGREDIENT)

Loratadine 10 mg

Other Information (OTHER INFORMATION)
  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments (QUESTIONS OR COMMENTS)

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

When Using This Product (WHEN USING THIS PRODUCT)

do not take more than directed. Taking more than directed may cause drowsiness.

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

you have liver or kidney disease. Your doctor should determine if you need a different dose.

Stop Use and Ask Doctor If (STOP USE AND ASK 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.


Advanced Ingredient Data


Raw Label Data

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