Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f1bcd2aa-e8cd-4364-87b4-c544537cdb50
Route
ORAL
Published
Effective Date 2022-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg) Pseudoephedrine (240 mg)
Inactive Ingredients
Calcium Carbonate Silicon Dioxide Lactose Monohydrate Magnesium Stearate Starch, Corn Shellac Sodium Alginate Sodium Citrate, Unspecified Form Talc Titanium Dioxide Ferrosoferric Oxide Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Microcrystalline Cellulose Povidone, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: RX724 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2017-02-15
Description

Loratadine, USP 10 mg Pseudoephedrine Sulfate, USP 240 mg

Purpose

Antihistamine Nasal Decongestant

Medication Information

Purpose

Antihistamine

Nasal Decongestant

Description

Loratadine, USP 10 mg Pseudoephedrine Sulfate, USP 240 mg

Uses

■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  •  
    ■ sneezing ■ itchy, watery eyes ■ runny nose ■ itching of the nose or throat

■ reduces swelling of nasal passages

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ temporarily restores freer breathing through the nose

Questions

call 1-800-406-7984

Directions

■ do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 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

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information
  •  
    ■ sodium: contains 10 mg/tablet ■ calcium: contains 25 mg/tablet

■ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)

■ store between 20° C to 25° C (68° F to 77° F).

■ protect from light and store in a dry place

Active Ingredients

Loratadine, USP 10 mg

Pseudoephedrine Sulfate, USP 240 mg

Inactiveingredients

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Principal Display Panel

NDC 70000-0162-2

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY**

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

15 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

Stop Use and Ask A Doctor If

■ an allergic reaction to this product occurs. Seek medical help right away.

■ symptoms do not improve within 7 days or are accompanied by a fever

■ nervousness, dizziness or sleeplessness occurs

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
  •  
    ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland

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

  •  
    .
Package/label Principal Display Panel

NDC 70000-0162-1

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY*

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

10 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

When Using This Product Do Not Take More Than Directed.

Taking more than directed may cause drowsiness.

Structured Label Content

Uses

■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  •  
    ■ sneezing ■ itchy, watery eyes ■ runny nose ■ itching of the nose or throat

■ reduces swelling of nasal passages

■ temporarily relieves sinus congestion and pressure

■ temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ temporarily restores freer breathing through the nose

Purpose

Antihistamine

Nasal Decongestant

Questions

call 1-800-406-7984

Directions

■ do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over

1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours

children under 12 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

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information
  •  
    ■ sodium: contains 10 mg/tablet ■ calcium: contains 25 mg/tablet

■ TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)

■ store between 20° C to 25° C (68° F to 77° F).

■ protect from light and store in a dry place

Active Ingredients (Active ingredients)

Loratadine, USP 10 mg

Pseudoephedrine Sulfate, USP 240 mg

Inactiveingredients (InactiveIngredients)

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

Principal Display Panel

NDC 70000-0162-2

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY**

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

15 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

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.

■ symptoms do not improve within 7 days or are accompanied by a fever

■ nervousness, dizziness or sleeplessness occurs

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)
  •  
    ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ trouble urinating due to an enlarged prostate gland

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

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

NDC 70000-0162-1

Original Prescription Strength

*Compare to the active ingredients of Claritin-D® 24 Hour

NON-DROWSY*

Allergy Relief D-24

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Allergy & Congestion

10 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Keep the carton. It contains important information.

see end panel for expiration date.

When Using This Product Do Not Take More Than Directed. (When using this product do not take more than directed.)

Taking more than directed may cause drowsiness.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:10.252356 · Updated: 2026-03-14T23:00:30.367061