target 686t loratadine 10 mg soft gels target ndc 11673-986-07 (10ct)11673-986-30 (30ct)

SPL v7

SPL

SPL Set ID 7cb1364b-0852-3444-e053-2991aa0a3629

Route

oral

Published

Effective Date 2019-04-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

loratadine (10 mg)

Inactive Ingredients

povidone glyceryl mono- and dicaprylocaprate fd&c blue no. 1 gelatin sorbitol water polysorbate 80

Identifiers & Packaging

Pill Appearance

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

Marketing Status

anda active Since 2019-04-10

Indications and Usage

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES: RUNNY NOSE ITCHY, WATERY EYES SNEEZING ITCHING OF THE NOSE OR THROAT

Description

Active ingredient (in each capsule) Loratadine 10 mg

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient (in each capsule)

Loratadine 10 mg

Indications and Usage

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:

RUNNY NOSE

ITCHY, WATERY EYES

SNEEZING

ITCHING OF THE NOSE OR THROAT

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

Inactive Ingredients

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

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 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Questions Or Comments?

Call 1-877-290-4008

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient (in each capsule)

Loratadine 10 mg

Indications and Usage (INDICATIONS AND USAGE)

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES:

RUNNY NOSE

ITCHY, WATERY EYES

SNEEZING

ITCHING OF THE NOSE OR THROAT

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

Inactive Ingredients (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 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 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Questions Or Comments? (Questions or comments?)

Call 1-877-290-4008

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONO- AND DICAPRYLOCAPRATE", "unii": "U72Q2I8C85", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "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", "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", "Inactive ingredients": "FD&C blue # 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution", "INDICATIONS AND USAGE": "TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO HAY FEVER OR OTHR UPPER RESPIRATORY ALLERGIES: RUNNY NOSE ITCHY, WATERY EYES SNEEZING ITCHING OF THE NOSE OR THROAT", "Questions or comments?": "Call 1-877-290-4008"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:32.316292 · Updated: 2026-03-14T23:07:28.673990