Loratadine Capsules, 10 mg Liquid-Filled Capsules Drug Facts

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-877-244-9825

Websitewww.strides.comwww.strides.com

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

• safety sealed: do not use if the  individual  blister unit imprinted with Loratadine capsule is open or torn
• store between 20° to 25°C (68° to 77°F)
• protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD & C Blue 1, Gelatin, Glycerin, Glyceryl Monocaprylocaprate, Isopropyl alcohol, Medium chain triglyceride, Polysorbate 80, Povidone K-30, Purified Water, Soya Lecithin, Sorbitol Solution,

Printing ink white-edible oil-Dewaxed Bleached Shellac Resins, Propylene Glycol, Sodium Lauryl Sulphate, Titanium Dioxide

.

Questions or comments?

OTC - QUESTIONS SECTION

Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com

Manufactured by:

Strides Pharma Science Limited

Bengaluru – 562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 01/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Loratadine
• FD&C BLUE NO. 1
• GELATIN
• GLYCERIN
• GLYCERYL CAPRYLATE/CAPRATE
• ISOPROPYL ALCOHOL
• LECITHIN, SOYBEAN
• MEDIUM-CHAIN TRIGLYCERIDES
• NONCRYSTALLIZING SORBITOL SOLUTION
• POLYSORBATE 80
• POVIDONE K30
• PROPYLENE GLYCOL
• SHELLAC
• SODIUM LAURYL SULFATE
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Orange Book application contexts#

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Orange Book products#

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Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

openFDA label cross-check#

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.