Timely Loratadine Tablets Usp, 10 Mg

Timely Loratadine Tablets Usp, 10 Mg
SPL v1
SPL
SPL Set ID 2c80ea14-8490-4d26-e063-6294a90aecf0
Route
ORAL
Published
Effective Date 2025-01-25
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 Silicon Dioxide Microcrystalline Cellulose 101 Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: 92 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2025-01-25

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
Section 51945-4

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.

Other Information
  • Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
  • store between 20º to 25º C (68º to 77º F)
  • FDA approved dissolution test specifications differ from USP
Inactive Ingredient

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

Call 1-877-290-4008

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).

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
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 51945-4 (51945-4)

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.

Other Information (Other information)
  • Tamper evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
  • store between 20º to 25º C (68º to 77º F)
  • FDA approved dissolution test specifications differ from USP
Inactive Ingredient (Inactive ingredient)

colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

Call 1-877-290-4008

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).

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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