Sig - 1195a - 2025-0430 - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Gelatin Capric Acid Povidone K30 Water Sorbitol Polysorbate 80 Sorbitan Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Imprint: 21 Shape: oval Color: blue Size: 3 mm Score: 1

Marketing Status

ANDA Active Since 2019-10-01

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, water 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 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 53414-9

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

Warnings

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

Directions

adults and children 6 years and over	1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete information and warnings

Inactive Ingredients

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Principal Display Panel

24 HR NON-DWOSY*

Compare to Claritin® Liqui-Gels® active ingredient†

NDC 21130-195-02

Signature Select®

ALLERGY RELIEF

SOFTGELS

LORATADINE 10mg / Antihistamine

Actual Size

Indoor and Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 SOFTGELS**

(**LIQUID-FILLED CAPSULES)

Active Ingredient (in Each Capsule)

Loratadine 10mg

Structured Label Content

Uses

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

• runny nose

• sneezing

• itchy, water 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 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 53414-9 (53414-9)

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

Purpose

Antihistamine

Warnings

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

Directions

adults and children 6 years and over	1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F)

• protect from freezing

• retain carton for complete information and warnings

Inactive Ingredients (Inactive ingredients)

FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

24 HR NON-DWOSY*

Compare to Claritin® Liqui-Gels® active ingredient†

NDC 21130-195-02

Signature Select®

ALLERGY RELIEF

SOFTGELS

LORATADINE 10mg / Antihistamine

Actual Size

Indoor and Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

10 SOFTGELS**

(**LIQUID-FILLED CAPSULES)

Active Ingredient (in Each Capsule) (Active Ingredient (in each capsule))

Loratadine 10mg

Advanced Ingredient Data

[{"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRIC ACID", "unii": "4G9EDB6V73", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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, water 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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "Warnings": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "Directions": "adults and children 6 years and over 1 capsule daily; not more than 1 capsule 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 20-25˚C (68-77˚F) • protect from freezing • retain carton for complete information and warnings", "Inactive ingredients": "FD&C Blue no. 1, gelatine, mono anddiglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80,povidone, purified water, sorbitol, sorbitan solution.", "PRINCIPAL DISPLAY PANEL": "24 HR NON-DWOSY* Compare to Claritin® Liqui-Gels® active ingredient† NDC 21130-195-02 Signature Select® ALLERGY RELIEF SOFTGELS LORATADINE 10mg / Antihistamine Actual Size Indoor and Outdoor Allergies Non-Drowsy* *When taken as directed. See Drug Facts Panel. Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 10 SOFTGELS** (**LIQUID-FILLED CAPSULES)", "Active Ingredient (in each capsule)": "Loratadine 10mg"}

Sig - 1195a - 2025-0430

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information