Loratadine and Pseudoephedrine Sulfate

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)	Purpose
Loratadine, USP 10 mg	Antihistamine
Pseudoephedrine sulfate, USP 240 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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 SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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 SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

• Loratadine and Pseudoephedrine Sulfate
• LORATADINE
• PSEUDOEPHEDRINE SULFATE
• PSEUDOEPHEDRINE
• CALCIUM CARBONATE
• HYPROMELLOSE, UNSPECIFIED
• FERROSOFERRIC OXIDE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• PROPYLENE GLYCOL
• SHELLAC
• SODIUM ALGINATE
• SODIUM CITRATE, UNSPECIFIED FORM
• TALC
• TITANIUM DIOXIDE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• STARCH, CORN
• POVIDONE, UNSPECIFIED
• HYDROXYPROPYL CELLULOSE (1600000 WAMW)
• SILICON DIOXIDE

NDC Codes#

Ingredients#

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Observed Orange Book product history#

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