Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 777e57a4-a9d7-4c8b-8fbf-d1a1abe2c1f9
Route
ORAL
Published
Effective Date 2012-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Aspartame Croscarmellose Sodium Magnesium Stearate Mannitol Sodium Stearyl Fumarate

Identifiers & Packaging

Pill Appearance
Imprint: RC17 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2007-08-31
Description

Loratadine USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

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
Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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
Do Not Use

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

Questions?

call 1-888-423-0139

Other Information
  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.
Inactive Ingredients

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

Principal Display Panel

Topcare ®

NDC 36800-527-69

MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

Original Prescription Strength

24 HOUR NON-DROWSY *

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

For Adults and Children six years and older!

For 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching Throat or Nose

COMPARE TO CLARITIN ® REDITABS ® active ingredient †

10 ORALLY DISINTEGRATING TABLETS

* When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095192/R812

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).

Active Ingredient (in Each Tablet)

Loratadine USP, 10 mg

Ask A Doctor Before Use If You Have

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

Structured Label Content

Uses (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 (PURPOSE)

Antihistamine

Directions (DIRECTIONS)
  • place 1 tablet on tongue; tablet disintegrates, with or without water
    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
Do Not Use (Do not use)

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

Questions? (QUESTIONS?)

call 1-888-423-0139

Other Information (OTHER INFORMATION)
  • Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
  • keep in a dry place.
  • use tablet immediately after opening individual blister.
Inactive Ingredients (INACTIVE INGREDIENTS)

Aspartame, croscarmellose sodium, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Topcare ®

NDC 36800-527-69

MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

Original Prescription Strength

24 HOUR NON-DROWSY *

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

For Adults and Children six years and older!

For 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itching Throat or Nose

COMPARE TO CLARITIN ® REDITABS ® active ingredient †

10 ORALLY DISINTEGRATING TABLETS

* When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095192/R812

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 (1-800-222-1222).

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Loratadine USP, 10 mg

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.775585 · Updated: 2026-03-14T22:53:23.299879