Loratadine Syrup

SPL v1

SPL

SPL Set ID 92f728c4-7cc9-4bef-b8a7-94df3f72cc44

Route

ORAL

Published

Effective Date 2011-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sucrose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2006-04-28

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7

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

Section 50569-3

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

Section 50570-1

Do not use if 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	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age	1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney disease	ask a doctor

Other Information

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive Ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.
side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Active Ingredient (in Each 5 Ml)

Loratadine 5 mg

Principal Display Panel 4 Fl Oz Label

(Loratadine

Oral Solution)

5 mg/5mL Antihistamine

4 FL OZ (120 mL)

NDC 54868-5580-0

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 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not use if 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	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age	1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney disease	ask a doctor

Other Information (Other information)

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive Ingredients (Inactive ingredients)

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

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.
side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Loratadine 5 mg

Principal Display Panel 4 Fl Oz Label (PRINCIPAL DISPLAY PANEL - 4 FL OZ Label)

(Loratadine

Oral Solution)

5 mg/5mL Antihistamine

4 FL OZ (120 mL)

NDC 54868-5580-0

Advanced Ingredient Data

[{"name": "Loratadine", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "citric acid monohydrate", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "propylene glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sodium metabisulfite", "unii": "4VON5FNS3C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "sucrose", "unii": "C151H8M554", "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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor", "Other information": "safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)", "Inactive ingredients": "artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away. side effects occur. You may report side effects to FDA at 1-800-FDA-1088.", "Active ingredient (in each 5 mL)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 4 FL OZ Label": "(Loratadine Oral Solution) 5 mg/5mL Antihistamine 4 FL OZ (120 mL) NDC 54868-5580-0"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:14.029887 · Updated: 2026-03-14T22:52:37.403989