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Loratadine and Pseudoephedrine Sulfate

Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Labeler
Major Pharmaceuticals
Label updated
2025-09-08
Retrieved
2026-09-07
Active ingredients
LORATADINE · PSEUDOEPHEDRINE SULFATE
View original label and images on DailyMed ↗
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 and 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. (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 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

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Label information

Distributed By
MAJOR ®PHARMACEUTICALS
Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton

MAJOR ®

NDC 0904-5833-15

compare to the active ingredients in
Claritin-D ®24 Hour**

non-drowsy*

loratadine-D

original prescription strength

pseudoephedrine sulfate, USP 240 mg

nasal decongestant
loratadine, USP 10 mg

antihistamine

24 hour

indoor & outdoor allergies

allergy & congestion

relief of:

nasal and sinus congestion due to colds or allergies

sneezing; runny nose; itchy, watery eyes;
itchy throat or nose due to allergies

*when taken as directed. see drug facts panel.

10 extended-release tablets

[Image in the official label — see DailyMed source]

DailyMed Set ID: 2620a150-4a2c-4fa2-a0e4-6aafe9e496c3 · Version 5
NDC: 0904-5833