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
Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Medication Information

Active Ingredient

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
Purpose

Antihistamine

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
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

Description

Loratadine USP, 10 mg

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

Questions?

call 1-888-423-0139

Do Not Use

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

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).

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

Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

Loratadine USP, 10 mg

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
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

Questions? (QUESTIONS?)

call 1-888-423-0139

Do Not Use (Do not use)

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

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).

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