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SPL v6

SPL

SPL Set ID 3b307aea-5a68-4c82-959a-cda4ffbd0a4a

Route

ORAL

Published

Effective Date 2013-11-15

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: G;L;10 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2011-06-01

Description

(in each tablet) Loratadine USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

(in each tablet) 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

PRODUCT PACKAGING

NDC 0378-8880-10

Original Prescription Strength

Non-Drowsy*

Loratadine

Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

•
Sneezing
•
Runny Nose
•
Itchy, Watery Eyes
•
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

RMX8880C1

100 Tablets

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 of kidney disease	ask a doctor

Do Not Use

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

Active Ingredient

(in each tablet)

Loratadine USP, 10 mg

Other Information

•
Tamper Evident: do not use if foil seal under cap is missing, open or broken.
•
store between 20° to 25°C (68° to 77°F)
•
protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions Or Comments?

call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

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

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)

PRODUCT PACKAGING

NDC 0378-8880-10

Original Prescription Strength

Non-Drowsy*

Loratadine

Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

•
Sneezing
•
Runny Nose
•
Itchy, Watery Eyes
•
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

RMX8880C1

100 Tablets

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 of 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.

Active Ingredient (Active ingredient)

(in each tablet)

Loratadine USP, 10 mg

Other Information (Other information)

•
Tamper Evident: do not use if foil seal under cap is missing, open or broken.
•
store between 20° to 25°C (68° to 77°F)
•
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Corn starch, lactose monohydrate and magnesium stearate.

Questions Or Comments? (Questions or comments?)

call 1-877-446-3679 (1-877-4-INFO-RX)

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

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

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "51945-4": "PRODUCT PACKAGING NDC 0378-8880-10 Original Prescription Strength Non-Drowsy* Loratadine Tablets USP, 10 mg Antihistamine Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. RMX8880C1 100 Tablets", "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 of kidney disease ask a doctor", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Active ingredient": "(in each tablet) Loratadine USP, 10 mg", "Other information": "• Tamper Evident: do not use if foil seal under cap is missing, open or broken. • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture", "Inactive ingredients": "Corn starch, lactose monohydrate and magnesium stearate.", "Questions or comments?": "call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:44.834572 · Updated: 2026-03-14T22:55:25.290849