loratadine liquid filled capsules, 10 mg (otc)

SPL v3

SPL

SPL Set ID c30907f9-1761-41e5-bd4e-2613e756e1c6

Route

oral

Published

Effective Date 2021-11-15

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 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 active Since 2016-10-01

Purpose

Antihistamine

Description

Loratadine 10mg

Medication Information

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

Purpose

Antihistamine

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 at 20°-25°C (68°-77°F)
protect from freezing.
Safety sealed: do not use if the individual blister unit imprinted with Loratadine Capsules is open or torn.

Inactive Ingredients

FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution.

Questions or comments?

Call at 1-877-376-4271

Description

Loratadine 10mg

Principal Display Panel

NDC# 25000-021-36

Loratadine Capsules, 10 mg

3x10 carton Label

Principal Display Panel

NDC# 25000-021-13

Loratadine Capsules, 10 mg

600 counts Bottle Label

NDC# 25000-021-34

Loratadine Capsules, 10 mg

28 counts Blister Pack

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Manufactured By

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, GOA 403722, India.

Manufactured For

Time-Cap Labs. Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

When Using This Product

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

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.

Active Ingredient (in Each Capsule)

Loratadine 10mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

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

Purpose

Antihistamine

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 at 20°-25°C (68°-77°F)
protect from freezing.
Safety sealed: do not use if the individual blister unit imprinted with Loratadine Capsules is open or torn.

Inactive Ingredients (Inactive ingredients)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC# 25000-021-36

Loratadine Capsules, 10 mg

3x10 carton Label

Principal Display Panel

NDC# 25000-021-13

Loratadine Capsules, 10 mg

600 counts Bottle Label

NDC# 25000-021-34

Loratadine Capsules, 10 mg

28 counts Blister Pack

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Manufactured By (Manufactured by)

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, GOA 403722, India.

Manufactured For (Manufactured for)

Time-Cap Labs. Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

When Using This Product (When using this product)

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

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.

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

Loratadine 10mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": ""}]

Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Antihistamine", "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.", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "Manufactured by": "Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate, Verna, GOA 403722, India.", "Manufactured for": "Time-Cap Labs. Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA", "Other information": "Store at 20°-25°C (68°-77°F) protect from freezing. Safety sealed: do not use if the individual blister unit imprinted with Loratadine Capsules is open or torn.", "Inactive ingredients": "FD&C blue no. 1, gelatin, mono and diglyceride of caprylic/capric acid, pharmaceutical ink, polysorbate 80, povidone, purified water, sorbitol sorbitan solution. Questions or comments? Call at 1-877-376-4271", "PRINCIPAL DISPLAY PANEL": "NDC# 25000-021-36 Loratadine Capsules, 10 mg 3x10 carton Label", "Principal Display Panel": "NDC# 25000-021-13 Loratadine Capsules, 10 mg 600 counts Bottle Label NDC# 25000-021-34 Loratadine Capsules, 10 mg 28 counts Blister Pack", "When using this product": "do not take more than directed. Taking more than directed may cause drowsiness.", "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.", "Active ingredient (in each capsule)": "Loratadine 10mg", "Ask a doctor before use if you have": "you have liver or kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:49.470811 · Updated: 2026-03-14T22:59:57.476249