1193-fir-2023-1101

SPL v2

SPL

SPL Set ID f6ce5292-f698-dd2f-e053-6394a90ad74a

Route

ORAL

Published

Effective Date 2023-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Starch, Corn Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2023-10-30

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Warnings and Precautions

Warnings

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Section 42229-5

Drug Facts

Section 50566-9

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

Section 50567-7

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

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 Information

store between 20 to 25°C (68 to 77°F)
retain carton for complete product information and warnings

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Questions Or Comments?

1-844-705-4384

Principal Display Panel

First Street®

NDC 61504-193-19

†COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®

NON-DROWSY*

Allergy Relief

24 HOUR

Loratadine Tablets

10 mg / Antihistamine

INDOOR & OUTDOOR ALLERGIES

For Relief of:

Sneezing • Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

ACTUAL SIZE

30 TABLETS

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

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

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

Other Information (Other information)

store between 20 to 25°C (68 to 77°F)
retain carton for complete product information and warnings

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

First Street®

NDC 61504-193-19

†COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®

NON-DROWSY*

Allergy Relief

24 HOUR

Loratadine Tablets

10 mg / Antihistamine

INDOOR & OUTDOOR ALLERGIES

For Relief of:

Sneezing • Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

ACTUAL SIZE

30 TABLETS

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

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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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 sneezing itchy, watery eyes itching of the nose or throat", "34071-1": "Warnings", "42229-5": "Drug Facts", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use", "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", "Other information": "store between 20 to 25°C (68 to 77°F) retain carton for complete product information and warnings", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate", "Questions or comments?": "1-844-705-4384", "PRINCIPAL DISPLAY PANEL": "First Street® NDC 61504-193-19 †COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN® NON-DROWSY* Allergy Relief 24 HOUR Loratadine Tablets 10 mg / Antihistamine INDOOR & OUTDOOR ALLERGIES For Relief of: Sneezing • Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL ACTUAL SIZE 30 TABLETS", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:12.826462 · Updated: 2026-03-14T23:01:38.303933