Topco Associates Llc. Allergy Relief Drug Facts

Topco Associates Llc. Allergy Relief Drug Facts
SPL v3
SPL
SPL Set ID 32f4e1d1-c830-4752-8251-bcc233bf03f6
Route
ORAL
Published
Effective Date 2021-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Crospovidone (15 Mpa.s At 5%) Hypromellose, Unspecified Magnesium Stearate Mannitol Microcrystalline Cellulose Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: L;L Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2020-06-25
Description

Loratadine 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 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.

Other Information
  • •
    do not use if printed blister unit is broken or torn
  • •
    store between 20° to 25°C (68° to 77°F)
  • •
    use tablet immediately after opening individual blister
Inactive Ingredients

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions Or Comments?

1-888-423-0139

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 10 mg

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

30 TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

Structured Label Content

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
Do Not Use (Do not use)

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

Other Information (Other information)
  • •
    do not use if printed blister unit is broken or torn
  • •
    store between 20° to 25°C (68° to 77°F)
  • •
    use tablet immediately after opening individual blister
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

30 TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:50.495944 · Updated: 2026-03-14T22:59:59.287312