Allergy relief d12 hour tablet, extended release

Active ingredients (in each tablet)

Loratadine 5 mg

Pseudoephedrine sulfate 120 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

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 Parkinsons 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 every 12 hours; not more than 2 tablets in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or

kidney disease

ask a doctor

Other information

  • each tablet contains: calcium 25 mg
  • do not use if blister unit is broken or torn
  • store between 20 to 25C (68 to 77F)
  • keep in a dry place

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Ingredients and appearance - Product information

Allergy relief d12 hour tablet, extended release- Loratadine, pseudoephedrine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 56062-013
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 5 mgin 1
Pseudoephedrine sulfate ( UNII: Y9DL7QPE6B)( Pseudoephedrine - UNII: 7CUC9DDI9F ) 120 mgin 1

Inactive Ingredients

Ingredient Name Code
Croscarmellose sodium ( UNII: M28OL1HH48)
Anhydrous dibasic calcium phosphate ( UNII: L11K75P92J)
Hypromelloses ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidone ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Size 12 mm
Shape ROUND Score 1

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076050 USA

Labeler - Publix Super Markets Inc( 006922009)

Package/label principal display panel

12-HOUR

allergy relief D

PSEUDOEPHEDRINE SULFATE 120 mg/NASAL DECONGESTANT

LORATADINE 5 mg/ANTIHISTAMINE

EXTENDED RELEASE TABLETS

ALLERGY & CONGESTION

NON-DROWSY*

Relief of:

nasal and sinus congestion due to colds or allergies

sneezing

runny nose

itchy, watery eyes

itchy throat or nose due to allergies

ACTUAL SIZE

INDOOR AND OUTDOOR ALLERGIES

20 EXTENDED RELEASE TABLETS

Compare to the active ingredients of Claritin-D® 12 hour Extended Release Tablets

*When taken as directed. See Drug Facts Panel.