1195a - Qch - 2018-0103 - 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 2018-09-01 Until 2026-07-31

Medication Information

Purpose

Antihistamine

Description

Loratadine 10mg

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

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 product information

Inactive Ingredients

FD&C blue #1, gelatin, mono and diglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol, sorbitan solution.

Questions Or Comments?

1-844-705-4384

Principal Display Panel

Quality Choice®

NDC 63868-669-10

*Compare to the Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy†

Allergy Relief

Loratadine 10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

†When taken as directed. See Drug Facts Panel.

10 Softgels**

**Liquid-Filled Capsules

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away

If Pregnant Or Breast Feeding,

ask a health professional before use.

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).

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

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 product information

Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, mono and diglyceride 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)

Quality Choice®

NDC 63868-669-10

*Compare to the Active Ingredient in CLARITIN® Liqui-Gels®

Non-Drowsy†

Allergy Relief

Loratadine 10 mg | Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

†When taken as directed. See Drug Facts Panel.

10 Softgels**

**Liquid-Filled Capsules

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

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

Loratadine 10mg

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "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", "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 product information", "Inactive ingredients": "FD&C blue #1, gelatin, mono and diglyceride of caprilic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol, sorbitan solution.", "Questions or Comments?": "1-844-705-4384", "PRINCIPAL DISPLAY PANEL": "Quality Choice® NDC 63868-669-10 *Compare to the Active Ingredient in CLARITIN® Liqui-Gels® Non-Drowsy† Allergy Relief Loratadine 10 mg | Antihistamine Indoor & Outdoor Allergies Relief of: Sneezing | Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 24 Hour †When taken as directed. See Drug Facts Panel. 10 Softgels** **Liquid-Filled Capsules", "When using this product": "do not take more than directed. Taking more than directed may cause drowsiness.", "Ask a doctor before use if": "you have liver or kidney disease. Your doctor should determine if you need a different dose.", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away", "If pregnant or breast-feeding,": "ask a health professional before use.", "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).", "Active Ingredient (in each capsule)": "Loratadine 10mg"}

1195a - Qch - 2018-0103

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information