Northstar Rxllc Loratadine Tablets Drug Facts

SPL v3

SPL

SPL Set ID f4ae9ed6-2936-f2f0-e053-2a95a90a14ee

Route

ORAL

Published

Effective Date 2023-02-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Povidone, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: L612 Shape: oval Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2019-02-20

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

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

do not use if printed foil under cap is broken or missing
store between 20 ^° to 25 ^°C (68 ^° to 77 ^°F)

Inactive Ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions Or Comments?

1-800-206-7821

Principal Display Panel

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 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

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)

do not use if printed foil under cap is broken or missing
store between 20 ^° to 25 ^°C (68 ^° to 77 ^°F)

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions Or Comments? (Questions or comments?)

1-800-206-7821

Principal Display Panel

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 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

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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", "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": "if you have ever had an allergic reaction to this product or any of its ingredients", "Other information": "do not use if printed foil under cap is broken or missing store between 20 ° to 25 ° C (68 ° to 77 ° F)", "Inactive ingredients": "lactose monohydrate, magnesium stearate, povidone, pregelatinized starch", "Questions or comments?": "1-800-206-7821", "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 10 mg", "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: 2026-02-15T12:03:07.061824 · Updated: 2026-03-14T23:02:58.626725