Loratadine 10mg Tablet
FDA Label NDC 25000-092

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Loratadine 10mg (NDC 25000-092). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, when using this product, stop use and ask doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Required Warnings

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient(S)

Active ingredient (in each tablet)
Loratadine USP, 10 mg

Purpose

Purpose
Antihistamine

Use(S)

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

Warnings

Do Not Use

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

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.

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 Doctor If

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

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).

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 Required Warnings

Other information

For Bottle pack: Tamper-evident: do not use this product if the imprinted foil seal over the mouth of the bottle is cut, torn, broken or missing.
For Blister pack: Tamper-evident: do not use if the individual blister unit is open or torn
store between 20° to 25° C (68° to 77° F)
FDA approved dissolution test specifications differ from USP

Inactive Ingredients

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

Questions Or Comments?

Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)

Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722

Made in India