Drug Facts 452

Drug Facts 452
SPL v2
SPL
SPL Set ID 5990445c-d522-24cf-e053-2991aa0af4e6
Route
ORAL
Published
Effective Date 2012-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2017-09-19
Description

Loratadine USP, 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Use(s)

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
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 and 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
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Active Ingredient(s)

Loratadine USP, 10 mg

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

NDC 67046-452-30

† Compare to the active ingredient of Claritin ®

NON-DROWSY *

24 Hour Allergy Relief

ohm ®

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

30 Tablets

When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5069178/0908

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.

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

Use(s) (USE(S))

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)
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 and 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)
  • store between 20 and 25° C (68 and 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Active Ingredient(s) (ACTIVE INGREDIENT(S))

Loratadine USP, 10 mg

Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 67046-452-30

† Compare to the active ingredient of Claritin ®

NON-DROWSY *

24 Hour Allergy Relief

ohm ®

Loratadine Tablets USP, 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

30 Tablets

When taken as directed. See Drug Facts Panel.

Manufactured by: Ohm Laboratories Inc.

5069178/0908

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.

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: 2026-02-15T11:56:43.336210 · Updated: 2026-03-14T22:55:23.037919