1. Home
  2. Labeler Index
  3. Chain Drug Consortium, Llc
  4. 68016-724
  5. Label Information: Loratadine And Pseudoephedrine Sulfate

FDA Label for Loratadine And Pseudoephedrine Sulfate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 10 TABLET BLISTER PACK CARTON

Loratadine And Pseudoephedrine Sulfate Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. 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.

Other



Drug Facts

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087


Otc - Purpose



Active ingredients (in each tablet)Purpose
Loratadine, USP 10 mgAntihistamine
Pseudoephedrine sulfate, USP 240 mgNasal 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 condtions, 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.

Otc - When Using



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

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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).


Directions



  • do not divide, crush, chew or dissolve the tablet
    • adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask 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.

Storage And Handling



  • 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 - 10 Tablet Blister Pack Carton



COMPARE TO THE ACTIVE
INGREDIENTS OF CLARITIN-D® 24 HOUR†

Original Prescription Strength
NON-DROWSY*

Premier
Value®

24 Hour Allergy Relief

Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

ALLERGY RELIEF and
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

    • 10
    Allergy & Congestion
    Extended-Release Tablets

    INDEPENDENTLY TESTED
    SATISFACTION GUARANTEED

    *When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton - allergy 01

    PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton - allergy 01


* Please review the disclaimer below.