Allergy Relief Tablet
FDA Label NDC 61504-193

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerifoods Trading Company for the product Allergy Relief (NDC 61504-193). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

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

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

Warnings

Warnings

Otc - Do Not Use

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

Otc - Ask Doctor

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

Otc - When Using

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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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 (1-800-222-1222).

Directions

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

  • store between 20 to 25°C (68 to 77°F)
  • retain carton for complete product information and warnings

Inactive Ingredients

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

Questions Or Comments?

1-844-705-4384

Principal Display Panel

First Street® 

NDC 61504-193-19

†COMPARE TO THE ACTIVE INGREDIENT IN CLARITIN®

NON-DROWSY*

Allergy Relief

24 HOUR

Loratadine Tablets

10 mg / Antihistamine

INDOOR & OUTDOOR ALLERGIES

For Relief of:

Sneezing • Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL

ACTUAL SIZE

30 TABLETS

Image Description (F1193a19fir R0)

Image Description (F1193a19fir R0)

* Please review the disclaimer below.