Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 96635cb0-8c78-4c3a-8294-2804ff26f90a
Route
ORAL
Published
Effective Date 2021-06-03
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 Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose, Unspecified Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Propylene Glycol Shellac Sodium Alginate Talc Titanium Dioxide Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: RX724 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2017-08-02

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Loratadine, USP 10 mg Pseudoephedrine sulfate, USP 240

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
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
Active Ingredient

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240

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.
  • store between 20 ° C to 25 ° C (68 ° F to 77 ° F)
  • protect from light and store in a dry
Inactive Ingredients

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

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
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.
Principal Display Panel 15 Tablet Blister Pack Carton

Compare to active ingredients in

Claratin-D® 24 hour**

NDC 46122-383-22

GOOD

NEIGHBOR

PHARMACY®

Non-Drowsy*

24 HOUR

Allergy &

Congestion Relief

pseudoephedrine sulfate, USP 240 mg/nasal decongestant

loratadine, USP 10 mg/antihistamine

Indoor & Outdoor Allergies

Extended-Release Tablets

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 tablets

*When taken as directed. See Drug Facts Panel.

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
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
Active Ingredient (Active ingredient)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240

Other Information (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.
  • store between 20 ° C to 25 ° C (68 ° F to 77 ° F)
  • protect from light and store in a dry
Inactive Ingredients (Inactive ingredients)

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

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
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.
Principal Display Panel 15 Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton)

Compare to active ingredients in

Claratin-D® 24 hour**

NDC 46122-383-22

GOOD

NEIGHBOR

PHARMACY®

Non-Drowsy*

24 HOUR

Allergy &

Congestion Relief

pseudoephedrine sulfate, USP 240 mg/nasal decongestant

loratadine, USP 10 mg/antihistamine

Indoor & Outdoor Allergies

Extended-Release Tablets

Relief of:

• Nasal and Sinus Congestion Due to Colds or Allergies

• Sneezing • Runny Nose • Itchy, Watery Eyes

• Itchy Throat or Nose Due to Allergies

15 tablets

*When taken as directed. See Drug Facts Panel.

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

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