Contac Allergy

SPL v1

SPL

SPL Set ID 4587a61d-139e-2a5b-e063-6394a90a1311

Route

ORAL

Published

Effective Date 2025-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Magnesium Stearate Sodium Starch Glycolate Type A Starch, Corn Lactose Monohydrate

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2026-02-01

Description

Active ingredient (in each tablet) Loratadine USP 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 tablet daily; not more than 1 tablet 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 tablet) Loratadine USP 10 mg

Section 42229-5

DISTRIBUTED BY:

Vespyr Brands ^®, LLC.

East Windsor, NJ 08520

Contac ^® is a registered trademark of Vespyr Brands ^®, LLC.

www.contac.com

Made in India

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Section 51945-4

NDC 71179-010-85

CONTAC _®

ALLERGY

Non-Drowsy*

Laratadine Tablets USP 10 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HR RELIEF

Relief of:

•Sneezing • Itchy, Watery Eyes

•Runny Nose • Itchy Throat or Nose

Section 53413-1

Questions or comments?

call 1-855-874-0970 Mon-Fri 8am - 5pm EST

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 tablet)

Loratadine USP 10 mg

Other Information

•Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken

•store at 20° to 25°C (68° to 77°F)

•protect from excessive moisture

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 tablet daily; not more than 1 tablet 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 42229-5 (42229-5)

DISTRIBUTED BY:

Vespyr Brands ^®, LLC.

East Windsor, NJ 08520

Contac ^® is a registered trademark of Vespyr Brands ^®, LLC.

www.contac.com

Made in India

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Section 51945-4 (51945-4)

NDC 71179-010-85

CONTAC _®

ALLERGY

Non-Drowsy*

Laratadine Tablets USP 10 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HR RELIEF

Relief of:

•Sneezing • Itchy, Watery Eyes

•Runny Nose • Itchy Throat or Nose

Section 53413-1 (53413-1)

Questions or comments?

call 1-855-874-0970 Mon-Fri 8am - 5pm EST

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 tablet)

Loratadine USP 10 mg

Other Information (Other information)

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "34071-1": "Warnings", "42229-5": "DISTRIBUTED BY: Vespyr Brands ® , LLC. East Windsor, NJ 08520 ©2025 Vespyr Brands ® , LLC. All rights reserved. Contac ® is a registered trademark of Vespyr Brands ® , LLC. www.contac.com Made in India", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "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 lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.", "51945-4": "NDC 71179-010-85 CONTAC ® ALLERGY Non-Drowsy* Laratadine Tablets USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HR RELIEF Relief of: •Sneezing • Itchy, Watery Eyes •Runny Nose • Itchy Throat or Nose", "53413-1": "Questions or comments? call 1-855-874-0970 Mon-Fri 8am - 5pm EST", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each tablet) Loratadine USP 10 mg", "Other information": "•Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken •store at 20° to 25°C (68° to 77°F) •protect from excessive moisture"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.092765 · Updated: 2026-03-14T23:12:40.778283