Loratadine and Pseudoephedrine

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Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240

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

Ask a doctor before use if you have

OTC - ASK DOCTOR/PHARMACIST 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

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

Other information

OTHER SAFETY 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

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

PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to active ingredients in
Claratin-D^® 24 hour**

NDC 46122-383-22

GOOD
NEIGHBOR
PHARMACY^®

Non-Drowsy*
24 HOUR

Allergy &
Congestion Relief
pseudoephedrine sulfate, USP 240 mg/nasal decongestant
loratadine, USP 10 mg/antihistamine

Indoor & Outdoor Allergies

Extended-Release Tablets

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

15 tablets

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

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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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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