OTC - ACTIVE INGREDIENT

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

OTC - PURPOSE

Antihistamine

Nasal decongestant

INDICATIONS & USAGE

• 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

• 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.

• 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.

Taking more than directed may cause drowsiness.

• 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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

• do not divide, crush, chew or dissolve the tablet

SPL UNCLASSIFIED

• sodium: contains 10 mg/tablet
• calcium: contains 25 mg/tablet
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
• store between 20° C to 25° C (68° F to 77° F).
• protect from light and store in a dry place

INACTIVE INGREDIENT

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

OTC - QUESTIONS

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By

MAJOR PHARMACEUTICALS

31778 Enterprise Drive, LIVONIA,

MI 48150, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Loratadine and Pseudoephedrine Sulfate

GENERIC: Loratadine and Pseudoephedrine Sulfate

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 61786-143-57

ACTIVE INGREDIENT(S):

• LORATADINE 10mg in 1
• PSEUDOEPHEDRINE SULFATE 240mg in 1

INACTIVE INGREDIENT(S):

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

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 17 mm

IMPRINT: RX724

PACKAGING: 5 in 1 BOTTLE