Gds - 1195a - 2022-1118 - DailyMed Details

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 Completed Since 2018-12-01 Until 2026-07-31

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 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 53414-9

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

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.

Questions Or Comments?

1-844-705-4384

Principal Display Panel

GOODSENSE®

NDC 50804-840-10

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

24 Hour

Allergy Relief

Loratadine Capsules, 10mg / Antihistamine

Indoor & Outdoor Allergies

• Sneezing •Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

10 SOFTGELS**

(**Liquid-Filled Capsules)

Compare to the active ingredient of Claritin® Liqui-Gels®

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 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 53414-9 (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 (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.

Questions Or Comments? (Questions or Comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

GOODSENSE®

NDC 50804-840-10

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

24 Hour

Allergy Relief

Loratadine Capsules, 10mg / Antihistamine

Indoor & Outdoor Allergies

• Sneezing •Runny Nose

• Itchy, Watery Eyes • Itchy Throat or Nose

10 SOFTGELS**

(**Liquid-Filled Capsules)

Compare to the active ingredient of Claritin® Liqui-Gels®

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.", "Questions or Comments?": "1-844-705-4384", "PRINCIPAL DISPLAY PANEL": "GOODSENSE® NDC 50804-840-10 Non-Drowsy* *When taken as directed. See Drug Facts Panel. 24 Hour Allergy Relief Loratadine Capsules, 10mg / Antihistamine Indoor & Outdoor Allergies • Sneezing •Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 10 SOFTGELS** (**Liquid-Filled Capsules) Compare to the active ingredient of Claritin® Liqui-Gels®", "Active Ingredient (in each capsule)": "Loratadine 10mg"}

Gds - 1195a - 2022-1118

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information