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

Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Loratadine 10 mg

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

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

Description

Drug Facts

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

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

Questions Or Comments?

1-844-705-4384

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).

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (Active ingredient (in each tablet))

Loratadine 10 mg

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

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

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

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

Questions Or Comments? (Questions or comments?)

1-844-705-4384

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).

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