Dye-free Loratadine Chewable Tablets Usp, 10 Mg

SPL v1

SPL

SPL Set ID 48744daa-7079-283d-e063-6394a90a2c9a

Route

ORAL

Published

Effective Date 2026-01-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Aspartame Anhydrous Citric Acid Silicon Dioxide Magnesium Stearate Mannitol Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 10 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

ANDA Active Since 2025-12-02

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
sneezing
itchy, watery eyes
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 (1-800-222-1222).

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 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.

Warnings

Directions

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 1 tablets daily; not more than 1 chewable tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.

Other Information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive Ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Active Ingredient (in Each Chewable Tablet)

Loratadine USP, 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton

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

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 (1-800-222-1222).

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 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

Warnings

Directions

chew or crush tablets completely before swallowing.

adults and children 6 years and over	chew 1 tablets daily; not more than 1 chewable tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

Keep the carton. It contains important information. See end panel for expiration date.

Other Information (Other information)

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

Inactive Ingredients (Inactive ingredients)

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Loratadine USP, 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

Advanced Ingredient Data

[{"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "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", "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 (1-800-222-1222).", "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": "chew or crush tablets completely before swallowing. adults and children 6 years and over chew 1 tablets daily; not more than 1 chewable tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984 . Keep the carton. It contains important information. See end panel for expiration date.", "Other information": "phenylketonurics: contains phenylalanine 1.25 mg per tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25°C (68° to 77°F).", "Inactive ingredients": "aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid", "Active ingredient (in each chewable tablet)": "Loratadine USP, 10 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:16.538405 · Updated: 2026-03-14T23:12:26.991151