Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE

Get an overview of LORATADINE AND PSEUDOEPHEDRINE SULFATE (tablet, film coated, extended release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Loratadine and Pseudoephedrine Sulfate can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Loratadine and Pseudoephedrine Sulfate.

Drug Basics

Brand Name: Loratadine and Pseudoephedrine Sulfate

Generic Name: LORATADINE AND PSEUDOEPHEDRINE SULFATE

Drug Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE

Data Current As Of: 2018-11-15

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

warnings

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 & 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

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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