Topcare Allergy Relief Capsule, Liquid Filled
FDA Label NDC 36800-755

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Allergy Relief (NDC 36800-755). 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 active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Capsule)

Loratadine 10 mg

Purpose

Antihistamine

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

Do Not Use

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

Ask A Doctor Before Use If You Have

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

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 (1-800-222-1222).

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

  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from freezing

Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, hydrolyzed collagen, hypromellose, isopropyl alcohol, mannitol, medium chain mono- & di-glycerides, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

1-888-423-0139

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COMPARE TO CLARITIN® LIQUI-GELS® ACTIVE INGREDIENT

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief Liquid-Gels

LORATADINE CAPSULES, 10 mg

ANTIHISTAMINE

OUR PHARMACISTS RECOMMEND

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 LIQUID-FILLED CAPSULES

*When taken as directed.

See Drug Facts Panel.

actual size

446-88-allergy-relief (Image 01)

446-88-allergy-relief (Image 01)

* Please review the disclaimer below.