686t Rite Aid 11822-0713 Loratadine Softgels 10 Mg 30 Ct

SPL v2

SPL

SPL Set ID dbf6c1e0-a920-0d09-e053-2995a90aba46

Route

ORAL

Published

Effective Date 2017-01-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Polysorbate 80 Povidone Water Sorbitol Caprylic/capric Mono/di-glycerides

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2022-06-15

Description

Active Ingredient (in each capsule) Loratadine 10 mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Dosage and Administration

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

Description

Active Ingredient (in each capsule) Loratadine 10 mg

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 51727-6

Inactive Ingredients FD&C blue # 1, gelatin, (mono and diglyceride of caprylic/capric acid), pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution

Section 51945-4

Section 53413-1

Questions or comments?

call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active Ingredient (in each capsule)

Loratadine 10 mg

Section 60561-8

Other information

• store between 20-25°C (68-77°F)

• protect from freezing

Structured Label Content

Indications and Usage (34067-9)

Uses

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

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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 51727-6 (51727-6)

Inactive Ingredients FD&C blue # 1, gelatin, (mono and diglyceride of caprylic/capric acid), pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active Ingredient (in each capsule)

Loratadine 10 mg

Section 60561-8 (60561-8)

Other information

• store between 20-25°C (68-77°F)

• protect from freezing

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": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "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": "CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES", "unii": "U72Q2I8C85", "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)

{"34067-9": "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat", "34068-7": "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", "34071-1": "Warnings", "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.", "51727-6": "Inactive Ingredients FD&C blue # 1, gelatin, (mono and diglyceride of caprylic/capric acid), pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution", "53413-1": "Questions or comments? call 1-877-290-4008", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active Ingredient (in each capsule) Loratadine 10 mg", "60561-8": "Other information • store between 20-25°C (68-77°F) • protect from freezing"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:14.623623 · Updated: 2026-03-14T23:00:37.728626