Good neighbor pharmacy loratadine d tablet, film coated, 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

Questions or comments?

1-800-719-9260

Ingredients and appearance - Product information

Good neighbor pharmacy loratadine d tablet, film coated, extended release- Loratadine, pseudoephedrine sulfate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 46122-455
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)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Povidone, unspecified ( UNII: FZ989GH94E)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (to off-white) Size 12 mm
Shape ROUND Score 1
Imprint Code 7U0

Marketing Information

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

Labeler - Amerisource Bergen( 007914906)

Package/label principal display panel

Compare to Claritin-D® 12 Hour

active ingredients

12 HOUR

Loratadine-D

pseudoephedrine sulfate 120 mg/Loratadine 5 mg

extended release tablets

nasal decongestant/antihistamine

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

indoor & outdoor allergies

allergy & congestion

Non-Drowsy*

actual size

*When taken as directed.

See Drug Facts Panel.

10 tablets