Loratadine and Pseudoephedrine Sulfate

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Full prescribing information#

ACTIVE INGREDIENTS (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

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 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

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.

When using this product do not take more than directed.

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.
• 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 1-888-423-0139

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare_®

NDC 36800-724-69

NON-DROWSY^*

24 HOUR

Original Prescription Strength

Allergy Relief - D

PSEUDOEPHEDRINE SULFATE, USP 240 mg/NASAL DECONGESTANT

LORATADINE, USP 10 mg/ANTIHISTAMINE EXTENDED RELEASE TABLETS

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Cold or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

10 EXTENDED RELEASE TABLETS

COMPARE TO CLARITIN-D^®24 HOUR active ingredients^†

^*When taken as directed. See Drug Facts Panel.

DIST.BY TOPCO ASSOCIATES LLC

5095191/R0412

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Products#

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• Loratadine and Pseudoephedrine Sulfate
• LORATADINE
• PSEUDOEPHEDRINE SULFATE
• PSEUDOEPHEDRINE
• CALCIUM CARBONATE
• COLLOIDAL SILICON DIOXIDE
• HYDROXYPROPYL CELLULOSE
• HYPROMELLOSES
• FERROSOFERRIC OXIDE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• POLYETHYLENE GLYCOLS
• POVIDONE
• STARCH, PREGELATINIZED CORN
• PROPYLENE GLYCOL
• SHELLAC
• SODIUM ALGINATE
• SODIUM CITRATE
• TALC
• TITANIUM DIOXIDE

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