Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID de3a7725-5d1b-4195-a9f8-43f92888997c
Route
ORAL
Published
Effective Date 2021-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 1-800-406-7984

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.
  • •
    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

† Compare To the active ingredient of Claritin ® RediTabs ®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY*

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

  •  
    • Melts in Your Mouth

24 HOUR

Relief of:

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

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

5217818/R0321

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 1-800-406-7984

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.
  • •
    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)

† Compare To the active ingredient of Claritin ® RediTabs ®

NDC 51660-527-31

ohm®

Original Prescription Strength

NON-DROWSY*

Ages 6 years and older

Loratadine Orally Disintegrating Tablets USP, 10 mg

ANTIHISTAMINE

Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

  •  
    • Melts in Your Mouth

24 HOUR

Relief of:

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

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: Ohm Laboratories Inc.

5217818/R0321

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: 2026-02-15T11:59:30.439532 · Updated: 2026-03-14T22:59:29.411693