1195a-qch-2024-0812

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2024-08-12

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

QUALITY CHOICE®

NDC 83324-103-10

†Compare to Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy*

Allergy Relief 24 Hour

Loratadine 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

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)

QUALITY CHOICE®

NDC 83324-103-10

†Compare to Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy*

Allergy Relief 24 Hour

Loratadine 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

10 SOFTGELS** **Liquid-Filled Capsules

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

Loratadine 10mg

Advanced Ingredient Data

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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": "QUALITY CHOICE® NDC 83324-103-10 †Compare to Active Ingredient in CLARITIN® Liqui-Gels® Non-Drowsy* Allergy Relief 24 Hour Loratadine 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 10 SOFTGELS** **Liquid-Filled Capsules", "Active Ingredient (in each capsule)": "Loratadine 10mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information