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 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.

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 reactions 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

STORAGE AND HANDLING 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 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY^®
CHOICE

NDC 63868-154-10

^†Compare to
Active Ingredients in
CLARITIN-D^® 24 Hour

Original Prescription Strength
Loratadine-D
Loratadine, USP 10 mg | Antihistamine
Pseudoephedrine Sulfate, USP 240 mg
Nasal Decongestant

Allergy Relief and Nasal Decongestant

Indoor & Outdoor Allergies
Relief of:
Nasal and Sinus Congestion Due to Colds or Allergies
Sneezing | Runny Nose | Itchy, Watery Eyes
Itchy Throat or Nose Due to Allergies

24 Hour Formula | Non-Drowsy*

10 Extended-Release Tablets
*When taken as directed.
See Drug Facts Panel.

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Products#

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

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• Loratadine and Pseudoephedrine Sulfate
• LORATADINE
• PSEUDOEPHEDRINE SULFATE
• PSEUDOEPHEDRINE
• CALCIUM CARBONATE
• SILICON DIOXIDE
• HYDROXYPROPYL CELLULOSE (1200000 MW)
• HYPROMELLOSE, UNSPECIFIED
• FERROSOFERRIC OXIDE
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• STARCH, CORN
• PROPYLENE GLYCOL
• SHELLAC
• SODIUM ALGINATE
• SODIUM CITRATE, UNSPECIFIED FORM
• TALC
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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