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  5. Label Information: Loratadine And Pseudoephedrine

FDA Label for Loratadine And Pseudoephedrine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT DO NOT TAKE MORE THAN DIRECTED.
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL

Loratadine And Pseudoephedrine Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Tablet)



Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg


Purpose



Antihistamine

Nasal decongestant


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

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.

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.

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.
  • •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).


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


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 place

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


Questions?



Call 1-800-406-7984


Principal Display Panel



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

ohm®

NDC 63187-305-10

NON-DROWSY*

24 Hour Allergy Relief

Original Prescription Strength

Allergy Relief & Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

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

    5 Extended-Release Tablets

    *When taken as directed. See Drug Facts Panel.

    Distributed by: Ohm Laboratories Inc.

    Repackaged by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

    5079399/R0610

    63187-305 - LoraD

    63187-305 - LoraD

    5’s blister carton

    5’s blister carton


* Please review the disclaimer below.