Allergy D Tablet, Extended Release
FDA Label NDC 0113-9004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L. Perrigo Company for the product Allergy D (NDC 0113-9004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product do not take more than directed., stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 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
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

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

  • do not use if printed blister unit is broken or torn
  • store between 20°-25°C (68°-77°F)
  • protect from light and store in a dry place

Inactive Ingredients

colloidal silicon dioxide, ferric oxide, hydrogenated vegetable oil, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, propylene glycol, titanium dioxide

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Claritin-D® 24 Hour active ingredients

ALLERGY & CONGESTION

allergy-D

Pseudoephedrine Sulfate 240 mg/Nasal Decongestant

Loratadine 10 mg/Antihistamine

Extended-Release Tablets

INDOOR & OUTDOOR ALLERGIES

24 Hour

Relief of:

• Nasal and Sinus Congestion Due to Cold or Allergies

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy, Throat or Nose Due to Allergies

*Non-Drowsy

*When taken as directed.

See Drug Facts Panel.

Actual Size

15 EXTENDED RELEASE TABLETS

2d8-55-allergy-d.jpg (2d8 55 Allergy D)

2d8-55-allergy-d.jpg (2d8 55 Allergy D)

* Please review the disclaimer below.